The Sr. Manager, Fill & Finish, Pckg. & Inspection Production Engineering provides strategic leadership and governance for production engineering activities within pharmaceutical manufacturing operations. This role ensures safe, compliant, and efficient production by owning process engineering, equipment performance, and lifecycle management across isolators, vial filling, stoppering, and capping systems. The role leads and develops a team of Senior Production Engineers and Production Engineers, driving asset performance, risk-based decision-making, and continuous improvement.
Role that this position reports to: Head of Reliability and Equipment Engineering
Role/s that report to this position: Sr. Production Engineers & Production Engineers
Main Responsibilities and Accountabilities: List the roles and responsibilities of the position
1Equipment Reliability & Operational Support
Responsible for overseeing the reliability, availability, and performance of equipment in various production areas. This role involves implementing proactive measures to identify and mitigate risks that could impact GMP, safety standards, and the continuity of supply.
Provide expert technical guidance for complex equipment issues, ensuring that the troubleshooting processes are systematic and methodical. Facilitate comprehensive root cause analysis to identify underlying problems and oversee the implementation of effective CAPA to resolve these issues and improve overall equipment reliability. Equipment includes, but is not limited to, vial washers, dehydrogenation tunnels, isolators, cappers, clean-in-place systems, clean-out-of-place systems, pasteurizers, and more.
Lead technical troubleshooting of complex deviations, sterility assurance issues, and equipment/process failures related to isolators and vial lines.
Establish and monitor reliability KPIs (e.g., MTBF, MTTR, maintenance effectiveness, OEE contributors) to drive continuous improvement.
2Maintenance & Asset Health Monitoring
Supervise the creation and enhancement of maintenance strategies that focus on preventive, predictive, and condition-based approaches. These strategies should be carefully aligned with the criticality of assets and the associated risks, ensuring that maintenance efforts are effectively prioritized and resources are utilized efficiently to prolong asset lifespan and reliability.
Ensure effective use of CMMS data (SAP) to monitor asset health, maintenance trends, and lifecycle cost performance.
Champion predictive maintenance technologies and digital asset monitoring initiatives.
3Change Management & Continuous Improvement
Govern equipment-related changes through formal change control processes, ensuring GMP compliance, risk assessment, and controlled implementation.
Lead and prioritize continuous improvement initiatives focused on asset reliability, compliance, cost optimization, and operational efficiency.
Ensure engineering standards, best practices, and procedures are established, maintained, and consistently applied.
4Asset Information & Lifecycle Management (ISO 55000 Alignment)
Own and implement the site Asset Management Strategy in alignment with ISO 55000/55001, ensuring consistency with corporate asset management objectives.
Ensure asset lifecycle governance across design, operation, maintenance, modification, and retirement of manufacturing equipment.
Oversee asset information management systems, ensuring data integrity, traceability, and accuracy across engineering documentation, CMMS (SAP), and asset registers.
Ensure asset criticality assessments, risk priority scoring, and asset performance targets are defined, maintained, and actively used to support decision-making.
5Projects & Shutdown Support
Accountable for the engineering portfolio of CapEx and OpEx equipment projects, including prioritization, resource allocation, and execution oversight.
Lead long-term asset lifecycle planning, including refurbishment, upgrade, and replacement strategies based on asset condition and business risk.
Provide leadership and governance for planned shutdowns, ensuring effective scope definition, execution, and post-shutdown performance review.
6
Compliance, Quality & Safety
Lead, coach, and develop Senior Production Engineers and Production Engineers, building technical capability in asset management, reliability engineering, and GMP compliance.
Set performance objectives aligned with asset management and operational goals and conduct regular performance and development reviews.
Foster a culture of ownership, accountability, continuous improvement, and cross-functional collaboration.
7People Leadership & Capability Development
Lead, coach, and develop Senior Production Engineers and Production Engineers, building technical capability in asset management, reliability engineering, and GMP compliance.
Set performance objectives aligned with asset management and operational goals and conduct regular performance and development reviews.
Foster a culture of ownership, accountability, continuous improvement, and cross-functional collaboration.
8Completes any other duties/responsibilities assigned by senior management
Position Qualifications and Experience Requirements:
Education
A bachelor’s degree in engineering (Chemical, Mechanical, Electrical) is required.
Master’s preferred
Experience
7+ years of experience in pharmaceutical fill & finish manufacturing, with deep expertise in isolator-based aseptic processing and vial filling
3–5+ years leading engineers or technical teams
Experience in leading day-to-day decisions and personnel management.
Ability to successfully lead projects from start to finish, ensuring they are completed on time, within budget, and meet high standards of quality.
Strong understanding of GMP, validation, and regulatory expectations
Experience with reliability engineering, maintenance strategies, and CMMS systems
Knowledge of biotech manufacturing processes (upstream/downstream/fill-finish as applicable)
Familiarity with automation and digital systems
Strategic thinker with the ability to translate complex engineering challenges into actionable programs
Knowledge of Six Sigma/Lean principles is a plus.
Competencies
Strong analytical and problem-solving skills.
Excellent communication abilities.
Innovation Leadership
Technical Expertise in Asset Management
Data-Driven Decision Making
Change Leadership & Transformation
Cross-Cultural Collaboration
Commitment to CSL values, ethical behavior, inclusive teamwork, and modeling a positive, respectful culture.
The expected base salary range for this position at hiring is $136,000- $171,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Read LessThe Opportunity:
The Global OT Partner Enablement Lead is accountable for establishing and governing the strategic technical framework by which external partners deliver operational and capital OT services across GxP manufacturing and laboratory systems, including PCS, MES, OSI PI, and LIMS platforms.
This role provides global governance for the technical aspects of supplier relationships, ensuring that master service agreements, quality plans, service agreements, maintenance agreements, partner KPIs, and platform lifecycle commitments are aligned to the enterprise OT strategy and consistently applied across all sites.
Additionally, this role is responsible for defining and managing the shared services operating model for OT partners, including enterprise services management and the global T1 project contracting templates used across all platforms, and for coordinating closely with functional contract owners so that partner performance, scope, and deliverables support reliable, compliant, and cost-effective execution of both operational support and capital project work throughout the OT ecosystem.
The Role:
Global OT Partner Governance & Shared Service Model -
Establish and maintain the global governance framework for OT partners, including strategic platform providers, strategic suppliers and shared service delivery models.
Define roles, responsibilities, and interfaces between Tier 1 partners, shared services, and internal teams to avoid overlap and gaps.
Ensure partner governance practices (reviews, escalations, approvals) are consistently applied across all regions and sites.
Drive adherence in collaboration with DQ and CSV to GxP, safety, and regulatory expectations in all partner-delivered services and projects.
Enterprise Services & Shared Services Structure-
Design and oversee the shared services structure for OT partner-delivered services (run, maintain, enhance) across PCS, MES, OSI PI, LIMS, and related platforms.
Define the global OT service catalog, SLAs/KPIs, and RACI for internal teams, shared services, and external partners.
Coordinate with global and site stakeholders to ensure services are right-sized, sustainable, and cost-effective.
Monitor service performance data and drive improvements in reliability, responsiveness, and quality of shared and partner-delivered services.
Contracting, MSAs & Project Templates-
Own and maintain global master service agreements, quality plans, service agreements, and maintenance agreements for strategic OT partners and shared services.
Develop, standardize, and continuously improve project contracting templates for use across all OT platforms and project types.
Partner with At-site E&M, Legal, Procurement, and functional contract owners to ensure contracts clearly define scope, deliverables, compliance, and pricing structures.
Periodically review and refresh contract terms to reflect evolving business needs, risk posture, and partner performance.
Partner Project Delivery Management-
Oversee partner project delivery quality for OT-related operational and capital projects, ensuring adherence to global standards, templates, and governance.
Establish expectations for partner project governance, documentation, testing, and handover to operations for all partner-led projects.
Capture and feed partner related project lessons learned into global standards, templates, and partner governance processes.
Platform Lifecycle & Enterprise Alignment-
Ensure partner and shared service agreements support the full lifecycle of OT platforms (introduction, expansion, upgrades, decommissioning).
Align partner responsibilities with platform roadmaps for PCS, MES, OSI PI, LIMS, and other OT enterprise applications.
Coordinate with OT Architecture, I&T, and platform owners to confirm lifecycle activities are contractually defined, resourced, and scheduled.
Track execution of lifecycle activities and drive corrective actions when deviations from standards, timelines, or quality expectations occur.
Local Alignment with the Global Partner & Shared Service Model-
Drive adoption of the global partner and shared service model at sites, ensuring local teams understand and operate within defined roles, processes, and contracts.
Partner with site Engineering, Automation, and Operations leaders to align local use of shared services and partners with the global model.
Identify local exception or special cases, and work to harmonize them or formalize controlled exceptions.
Provide coaching, communication, and change management support to reinforce the global partner and shared service strategy at the local level.
Performance Management & Strategic Relationship Leadership-
Define and maintain enterprise KPIs, scorecards, and review cadences for strategic OT partners and shared services.
Lead periodic performance and business reviews with partners and shared service leaders to address issues, risks, and opportunities for improvement.
Act as the primary escalation point for structural performance concerns or contractual disputes related to OT services.
Foster long-term, collaborative relationships with strategic partners and shared service teams that promote innovation, efficiency, and reliability across the OT ecosystem.
Skills & Experience:
Bachelor of Science in an Engineering, Automation, Computer Science or local equivalent.
10+ years’ work experience, with at least 5 years’ experience in execution systems, operational technology, IT and operations
Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95)
Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, DCS, MES, PAT, LIMS, Digital Methods, OSI Pi Data historian, etc.) in a regulated large-scale process-based manufacturing environment.
Experience writing, executing, and monitoring automation contract deliverables
Ability to work across a range of countries and cultures
Strong project management skills and experience in engineering projects within biopharma manufacturing.
Functional knowledge of cGMPs and manufacturing operations in FDA-regulated facilities.
Automation & Execution Systems Expertise
Project Management
Regulatory Compliance
Strategic Planning
Stakeholder Engagement
Strategic innovation
Delivering Enterprise Results and Value Orientation
About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Read LessThe Automation Supplier Execution Lead is accountable for establishing and governing the local technical framework by which external partners deliver operational and capital OT services across GxP manufacturing systems, including but not limited to PCS, MES, PLC, Lab Instrument and SCADA platforms. This role will align with global governance for the technical aspects of supplier relationships, ensuring that master service agreements, quality plans, service agreements, maintenance agreements, partner KPIs, and platform lifecycle commitments are monitored at each site for each local partner. Additionally, this role is responsible for executing and managing the local shared services operating model for OT partners, including local adoptions of enterprise services management and embedded engineering services.
Role that this position reports to: Site Automation HeadRole/s that report to this position: This role is an individual contributorResponsibilities:
1. Local OT Partner Governance & Shared Service Model
Execute against the local framework for OT partners, including strategic platform providers, strategic suppliers and shared service delivery models.Define and monitor roles, responsibilities, and interfaces between partners, shared services, and internal teams to avoid overlap and gaps.Ensure partner governance practices (costings, reviews, escalations, approvals) are consistently monitored.Drive adherence in collaboration with DQ and CSV to GxP, safety, and regulatory expectations in all partner-delivered services and projects.2. Enterprise Services & Shared Services Structure
Monitor the global OT service catalog, SLAs/KPIs, and RACI for internal teams, shared services, and external partners.Coordinate with global and site stakeholders to ensure services are right-sized, sustainable, and cost-effective.Monitor service performance data and drive improvements in reliability, responsiveness, and quality of shared and partner-delivered services.3. Contracting, MSAs & Project Templates
Own and maintain local adoption master service agreements, quality plans, service agreements, and maintenance agreements for strategic OT partners and shared services.Execute project contracting templates for use across all OT platforms and project types.Partner with Above-site E&M, Legal, Procurement, and functional contract owners to ensure contracts clearly define scope, deliverables, compliance, and pricing structures.Periodically review and refresh contract terms to reflect evolving business needs, risk posture, and partner performance.4. Partner Project Delivery Management
Oversee partner project delivery quality for OT-related operational and capital projects, ensuring adherence to global standards, templates, and governance.Establish expectations for partner project governance, documentation, testing, and handover to operations for all partner-led projects.Capture and feed partner related project lessons learned into global standards, templates, and partner governance processes.5. Platform Lifecycle & Enterprise Alignment
Ensure partner and shared service agreements support the full lifecycle of OT platforms (introduction, expansion, upgrades, decommissioning).Align local partner responsibilities with platform roadmaps for PCS, MES, OSI PI, LIMS, and other OT enterprise applications.Coordinate with OT Architecture, I&T, and platform owners to confirm lifecycle activities are contractually defined, resourced, and scheduled.Track local execution of lifecycle activities and drive corrective actions when deviations from standards, timelines, or quality expectations occur.6. Performance Management & Strategic Relationship Leadership
Monitor local KPIs, scorecards, and review cadences for strategic OT partners and shared services.Lead periodic performance and business reviews with partners and shared service leaders to address issues, risks, and opportunities for improvement.Act as the primary escalation point for structural performance concerns or contractual disputes related to OT services.Foster long-term, collaborative relationships with strategic partners and shared service teams that promote innovation, efficiency, and reliability across the OT ecosystem.
Education:
Experience:
10+ years’ work experience, with at least 5 years’ experience in execution systems, operational technology, IT and operationsSpecific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95) Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, DCS, MES, PAT, LIMS, Digital Methods, OSI Pi Data historian, etc.) in a regulated large-scale process-based manufacturing environment.Experience writing, executing, and monitoring automation contract deliverablesAbility to work across a range of countries and culturesStrong project management skills and experience in engineering projects within biopharma manufacturing.Functional knowledge of cGMPs and manufacturing operations in regulated facilities.Competencies:
Automation & Execution Systems ExpertiseProject ManagementRegulatory ComplianceStrategic PlanningStakeholder EngagementStrategic innovationDelivering Enterprise Results and Value OrientationThe expected base salary range for this position at hiring is $138,000 - $164,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Read LessPosition Purpose
The Utilities Engineer is responsible for oversight of design, engineering, safety and quality support in the following utility equipment systems:
Clean Utilities (Clean Steam, Purified Water, WFI and RO Systems), HVAC Systems, Plant Steam Systems, Co-Generation Units, Process Chillers, Compressed/Process Air, Ammonia Chillers and Refrigeration Process, Alcohol Distillation and Recovery Process, Process Gases, Natural Gas, Bulk Chemical Distribution, Solvent Gas Detection systems, Water, Cooling towers and Waste Treatment systems for the Kankakee facility.
This individual will work closely with a cross-functional team to meet the needs of the groups they support.
Responsibilities
1 Technical lead accountable for the operational improvement of the utility systems based upon industry trends and emerging technologies:
Responsible for compliance and operational improvement of equipment systems
Provide engineering support to address operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life
Implement measures to improve equipment that support utility operations
Provide technical expertise and industry best practices
Lead engineering efforts to resolve equipment and operational problems and ensure problem solving techniques are appropriately utilized
Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments and participates in validation activities including review of IQ/OQ protocols, executions and summary reports.
Provide technical support to operations, maintenance, manufacturing, automation, quality assurance, validation, reliability engineering and project engineering.
Support the planning and execution of activities by working in cross-functional teams assisting in driving projects to completion to meet timeline and budget objectives
Manage system documentation including creation, review, updates, and approval of technical specifications, operating procedures, and system drawings.
2 Accountable for the Utility Reliability Program:
Execute the maintenance strategy for new and modified equipment
Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements
Develop preventative maintenance procedures for utility systems in collaboration with the Reliability Engineering department ensuring maintenance programs are implemented
Continuous Improvement of maintenance PM’s, BOM’s and Spare Parts
Review and lead utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.
Oversees reconditioning of the equipment to restore to like-new condition
Performs upgrades to improve safety, operational performance, and extend operational life
Collaborates with local and global partners to develop asset management plan that includes capital requests
3 Manage and monitor KPI’s:
Ensure compliance with site and global indicators
Measure and ensure compliant performance in Safety, Quality and Reliability
Demonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics
Utilize control systems to monitor, trend and verify equipment performance and downtime
4 Ensure cGMP compliance of all utility systems to meet regulatory compliance:
Equipment is maintained at a level required to provide high reliability maximizing useful life
Review environmental monitoring and laboratory sample release test results
Manage deviations, investigations (CAPA’s and OOT’s) with on-time closure
Safely resolve process problems, improve efficiency, reduce waste, and maximize uptime production
Execute root cause analysis during investigations
Lead investigations as the subject matter expert providing technical expertise for all phases associated with the utility systems
Responsible for the development and maintenance of the utility drawings, flow diagrams and Standard Operational documents.
Perform utility inspections for quality assurance on a periodic basis and initiate any procedures necessary to resolve problems
Responsible for utility inspections (GEMBA’s/audits) for quality assurance on a periodic basis.
Responsible to ensure training, deviations and investigations related to utility systems have on-time closure and KPI performance metrics are met
Responsible for change control activities, the implementation of CAPA items, quality investigations and determine/implement long lasting corrective actions and preventative measures.
5 Support scheduled capital project related utility system shutdowns, tie-ins and system startup.
6 Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to biopharmaceutical industry engineering best practices and technologies, as well as technical understanding/problem solving capability.
7 Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
8 Completes any other duties/responsibilities assigned by senior management.
Additional Responsibilities and Accountabilities (Clean System):
1 Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the Clean Utility systems.
2 Play an essential leadership role in support of the operation on project support activities.
3 Responsible for the Clean Utility generation and distribution systems across the site. These systems include clean steam, purified water, clean air, WFI, clean gases and other ancillary equipment
4 Responsible for the quality requirements and the applicable regulatory standards, such as USP, EU and JP.
5 Technical lead in engineering, with a focus on pharmaceutical utility systems, industry best practices, and emerging technologies related to utility systems requirements.
Additional Responsibilities and Accountabilities (Plant System):
1 Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the Plant Utility systems.
2 Play an essential leadership role in support of the operation on project support activities.
3 Responsible for the Utility generation and distribution systems across the site. These systems include domestic/potable/industrial water, cooling tower water, soft water, plant steam (boilers and cogen), gas and other ancillary equipment
4 Technical lead in engineering, with a focus on plant utility systems, industry best practices, and emerging technologies related to utility systems requirements.
Qualifications
Education: Bachelor’s Degree in Chemical, Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field.
Experience
· 5+ years of relevant experience and a BS
· 3+ years of relevant experience and a MS
· Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.)
· Strong knowledge of utility systems (Clean and Plant Utility Systems)
· Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR’s.
· Must have experience with mid-to-large capital projects for the pharmaceutical industry.
· Knowledge of biopharmaceutical process operation and process control, utility and mechanical systems (pumps, valves, materials).
· Working knowledge of pharmaceutical process sanitary connections, valves and supply loops.
· Experience with Quality Management and Change Control Systems.
· Knowledge of computerized maintenance management systems (CMMS).
· Excellent problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision.
· Demonstrated ability to manage contractors, while interfacing with multiple departments, working with internal customers to manage projects.
· Knowledge of manufacturing processes
The expected base salary range for this position at hiring is $98,000 - $124,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Read LessThe Utilities Engineer is responsible for oversight of design, engineering, safety and quality support in the following utility equipment systems:
Clean Steam, Purified Water, WFI and RO Systems, HVAC Systems, Plant Steam Systems, Co-Generation Units, Process Chillers, Compressed/Process Air, Nitrogen, Ammonia Chillers and Refrigeration Process, Alcohol Distillation and Recovery Process, Process Gases, Natural Gas, Bulk Chemical Distribution, Solvent Gas Detection systems, Fire Alarm, Control and Protection Systems, Electrical Systems, Water, Cooling towers and Waste Treatment systems for the Kankakee facility.
This individual will work closely with a cross-functional team to meet the needs of the groups they support.
Role that this position reports to: Sr. Manager, Utilities Engineering
Positions reporting into this role: N/A
Responsibilities:
1.Technical lead accountable for the operational improvement of the utility systems based upon industry trends and emerging technologies:
Responsible for compliance and operational improvement of equipment systems
Provide engineering support to address operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life
Implement measures to improve equipment that support utility operations
Provide technical expertise and industry best practices
Lead engineering efforts to resolve equipment and operational problems and ensure problem solving techniques are appropriately utilized
Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments and participates in validation activities including review of IQ/OQ protocols, executions and summary reports.
Provide technical support to operations, maintenance, manufacturing, automation, quality assurance, validation, reliability engineering and project engineering.
Support the planning and execution of activities by working in cross-functional teams assisting in driving projects to completion to meet timeline and budget objectives
Manage system documentation including creation, review, updates, and approval of technical specifications, operating procedures, and system drawings.
2.Accountable for the Utility Reliability Program:
Execute the maintenance strategy for new and modified equipment
Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements
Develop preventative maintenance procedures for utility systems in collaboration with the Reliability Engineering department ensuring maintenance programs are implemented
Continuous Improvement of maintenance PM’s, BOM’s and Spare Parts
Review and lead utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.
Oversees reconditioning of the equipment to restore to like-new condition
Performs upgrades to improve safety, operational performance, and extend operational life
Collaborates with local and global partners to develop asset management plan that includes capital requests
3.Manage and monitor KPI’s:
Ensure compliance with site and global indicators
Measure and ensure compliant performance in Safety, Quality and Reliability
Demonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics
Utilize control systems to monitor, trend and verify equipment performance and downtime
4.Ensure cGMP compliance of all utility systems to meet regulatory compliance:
Equipment is maintained at a level required to provide high reliability maximizing useful life
Review environmental monitoring and laboratory sample release test results
Manage deviations, investigations (CAPA’s and OOT’s) with on-time closure
Safely resolve process problems, improve efficiency, reduce waste, and maximize uptime production
Execute root cause analysis during investigations
Lead investigations as the subject matter expert providing technical expertise for all phases associated with the utility systems
Responsible for the development and maintenance of the utility drawings, flow diagrams and Standard Operational documents.
Perform utility inspections for quality assurance on a periodic basis and initiate any procedures necessary to resolve problems
Responsible for utility inspections (GEMBA’s/audits) for quality assurance on a periodic basis.
Responsible to ensure training, deviations and investigations related to utility systems have on-time closure and KPI performance metrics are met
Responsible for change control activities, the implementation of CAPA items, quality investigations and determine/implement long lasting corrective actions and preventative measures.
5.Support scheduled capital project related utility system shutdowns, tie-ins and system startup.
6.Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to biopharmaceutical industry engineering best practices and technologies, as well as technical understanding/problem solving capability.
7.Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
8.Completes any other duties/responsibilities assigned by senior management.
Additional Responsibilities and Accountabilities (HVAC):
1.Responsible for HVAC cGMP facility design and improvement projects in Cleanrooms, Labs, etc.
2.Responsible for review and approval of Building HEPA Certification Filter and Testing Air Balance reports ensuring compliance to regulatory and industry standards (ISO).
3.Technical expertise in all systems (GMP and non-GMP HVAC and ancillary systems associated within their operations), understanding their applications in pharmaceutical manufacturing, understanding pressure cascade, flow charts and process parameters.
4.Assess HVAC equipment and prepare required reports.
Additional Responsibilities and Accountabilities (Clean System):
1.Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the Clean Utility systems.
2.Play an essential leadership role in support of the operation on project support activities.
3.Responsible for the Clean Utility generation and distribution systems across the site. These systems include clean steam, purified water, clean air, WFI, clean gases and other ancillary equipment
4.Responsible for the quality requirements and the applicable regulatory standards, such as USP, EU and JP.
5.Technical lead in engineering, with a focus on pharmaceutical utility systems, industry best practices, and emerging technologies related to utility systems requirements.
Qualifications:
Bachelor's Degree in Chemical, Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field.
5+ years' experience as a utilities/facilities engineer with BS; 3+ years' experience as a utilities/facilities engineer with MS.
Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.)
Strong knowledge of utility systems (Clean and Plant Utility Systems)
Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR’s.
Must have experience with mid-to-large capital projects for the pharmaceutical industry.
Knowledge of biopharmaceutical process operation and process control, utility and mechanical systems (pumps, valves, materials).
Working knowledge of pharmaceutical process sanitary connections, valves and supply loops.
Experience with Quality Management and Change Control Systems.
Knowledge of computerized maintenance management systems (CMMS).
Excellent problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision.
Demonstrated ability to manage contractors, while interfacing with multiple departments, working with internal customers to manage projects.
Knowledge of manufacturing processes
Computer skills: MS Project and AutoCAD preferred
The expected base salary range for this position at hiring is $98,000 - $124,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Read LessPosition Purpose:
The Senior Production Engineer provides technical leadership and strategic engineering support to pharmaceutical manufacturing operations, ensuring optimal asset performance, reliability, and compliance throughout the asset lifecycle. This role drives risk-based asset management strategies
in alignment with ISO 55000 principles, GMP requirements, and business objectives, while partnering with Production, Maintenance, Quality, and Capital Projects teams.
Reporting Relationships:
▪ Role that this position reports to:
Main Responsibilities and Accountabilities: List the roles and responsibilities of the position.
1) Process & Equipment Engineering
▪ Provide senior-level frontline engineering support for complex equipment issues, leading structured troubleshooting and failure investigations. Such as, but not limited to separation, extraction, purification and filling processes.
▪ Support fractionation, bulk or fill finish systems including design, operation, and lifecycle management.
▪ Provide engineering oversight for centrifuges, filter presses, chromatography
columns, ultra-filtration and diafiltration, clean-in-place, clean out of place, aseptic transfer technologies etc
▪ Ensure robust GMP practices and contamination control throughout operations.
▪ Lead Root Cause Analysis (RCA) using recognized methodologies (e.g., FMEA, 5- Why, Fishbone) and ensure effective implementation of CAPAs.
▪ Define and drive equipment reliability strategies to improve availability,
performance, and lifecycle cost.
2) Maintenance & Asset Health Monitoring
▪ Develop, review, and optimize preventive and predictive maintenance strategies based on asset criticality, historical performance, and condition monitoring data.
▪ Analyze asset health using CMMS data (SAP), including MTBF, MTTR, OEE
contributors, and maintenance effectiveness KPIs.
▪ Champion predictive maintenance technologies and condition-based monitoring to reduce unplanned downtime and asset risk.
3) Change Management & Continuous Improvement
▪ Lead equipment-related changes through formal change control processes and investigations, ensuring GMP compliance, data integrity, and controlled risk.
▪ Drive continuous improvement initiatives focused on asset reliability, compliance, and operational efficiency, aligned with site and corporate asset management objectives.
▪ Work to improve equipment reliability as measured by Operational Equipment
Effectiveness (OEE).
▪ Mentor junior engineers and technicians in reliability engineering, asset
management principles, and GMP-compliant engineering practices.
▪ Rotation between value streams
▪ Provide technical training on aseptic equipment and best practices.
4) Asset Information & Lifecycle Management (ISO 55000 Alignment)
▪ Own and govern asset information across the lifecycle, ensuring integrity,
traceability, and alignment with ISO 55000 Asset Information Management
requirements, including URS, FS/DS, P&IDs, equipment files, and SAP CMMS
records.
▪ Lead asset criticality assessments and risk-based prioritization using failure
modes, risk priority numbers (RPNs), and business impact analysis to support
maintenance and investment decisions.
▪ Ensure alignment between asset performance objectives, site asset management plans, and production demand.
5) Projects & Shutdown Support
▪ Lead equipment-related projects funded through Capital Expenditure (CapEx) or Operational Expenditure (OpEx), including scope definition, business case
development, risk assessment, and execution.
▪ Provide engineering leadership during planned shutdowns, including scope
planning, resource coordination, execution oversight, and post-shutdown
performance review.
▪ Support equipment lifecycle decisions, including refurbishment, upgrade, and
replacement strategies based on asset condition and business risk.
6) Compliance, Quality & Safety
▪ Ensure engineering activities comply with GMP, EHS, and ISO 55000/55001
requirements.
▪ Author, review, and approve SOPs/, change controls, deviations, investigations and CAPAs.
▪ Lead and support qualification and validation activities (IQ/OQ/PQ), ensuring
engineering documentation supports regulatory inspections and audits.
▪ Act as a subject matter expert during internal and external audits related to
equipment, asset management, and reliability.
7) Completes any other duties/responsibilities assigned by senior management
Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.
Education
▪ Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or
related field).
▪ Master’s degree in Engineering or related field preferred
Experience
▪ 5+ years of engineering experience in pharmaceutical manufacturing.
▪ Experience in Aseptic, Bulk, or Fractionation processing expertise
▪ Technical problem-solving, investigation and root cause analysis
▪ Knowledge of Six Sigma/Lean principles is a plus.
▪ Strong knowledge of sterile filling operations, aseptic techniques, and
contamination control.
▪ Proven ability to successfully lead projects from start to finish, ensuring
they are completed on time, within budget, and meet high standards of
quality.
▪ Proven experience supporting cGMP environments and regulatory
inspections.
▪ Knowledge of Six Sigma/Lean principles is a plus.
Competencies
▪ Strategic Planning & Execution
▪ Continuous Improvement & Lean/Six Sigma
▪ Team Leadership & Development
▪ Analytical Problem Solving
▪ Stakeholder Engagement & Communication
▪ Cross-functional collaboration
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Read LessThis role is accountable for the end-to-end execution of complex capital projects (T2&T3) within a cGMP-regulated environment, ensuring delivery aligned with business priorities, regulatory expectations, and CSL’s engineering and quality standards. The Project Engineering, Associate Director partners cross-functionally to translate strategic objectives into executable projects that enhance capacity, capability, and compliance across the manufacturing.
Role that this position reports to: Head of Project Engineering
Main Responsibilities and Accountabilities:
Engineering Leadership
▪ Provide strategic and technical leadership across engineering disciplines, including process, mechanical, electrical, automation, and facilities.
▪ Ensure engineering solutions are robust, scalable, and compliant with cGMP, ISPE, and internal CSL standards.
▪ Review and approve key engineering deliverables (e.g., URS, design specifications, P&IDs, technical packages).
▪ Support technology transfers, process improvements, and facility expansions.
Project Delivery & Execution Excellence
▪ Lead the full lifecycle of capital projects (typically $1MM–$50MM+), from concept through design, procurement, construction, commissioning, and qualification (CQV).
▪ Translate business needs into clearly defined project scopes, timelines, and resource plans.
▪ Ensure consistent application of CSL project management standards, governance, and stage-gate processes.
▪ Proactively manage risks, issues, and change controls to ensure predictable project outcomes.
Quality & Compliance
▪ Ensure all project activities meet global regulatory requirements (FDA, EMA) and CSL Quality standards.
▪ Oversee commissioning, qualification, and validation strategies (IQ/OQ/PQ) to ensure inspection readiness.
▪ Partner with Quality and Validation to maintain a state of compliance throughout project execution.
Stakeholder Partnership
▪ Serve as a trusted partner to Engineering, Manufacturing, Quality, Supply Chain, Validation, and EHS functions.
▪ Provide clear, data-driven updates to senior leadership on project status, risks, and financial performance.
▪ Build and manage effective relationships with external partners, including EPC firms, OEMs, and contractors.
Safety, Health & Environment (EHS)
▪ Champion a zero-harm safety culture across all project phases, ensuring safety is the top priority in design and execution.
▪ Ensure compliance with all applicable EHS regulations (OSHA, EPA) and CSL global safety standards.
▪ Integrate safety-by-design principles (e.g., risk assessments, safety work permits) into engineering and project delivery.
▪ Lead contractor safety management, including prequalification, onboarding, and on-site oversight.
▪ Ensure robust incident prevention, reporting, and corrective action processes are in place.
▪ Partner with EHS to ensure safe execution during construction, commissioning, and startup activities.
Financial Stewardship
▪ Develop, manage, and forecast capital expenditure (CapEx) budgets in alignment
with approved business cases.
▪ Drive disciplined cost management and identify opportunities for efficiency without
compromising safety or quality.
▪ Ensure transparency in financial reporting and adherence to CSL's financial control
People Leadership & Culture
▪ Lead, coach, and develop a high-performing team of project engineers and external resources.
▪ Foster a culture of accountability, inclusion, safety, and continuous improvement consistent with CSL values.
▪ Build organizational capability through mentoring and talent development.
Operational Excellence
▪ Champion standardization and continuous improvement in project delivery processes.
▪ Apply Lean and Six Sigma principles to improve efficiency and reduce variability.
▪ Promote a strong safety culture and ensure EHS requirements are embedded in all project activities.
Education:
▪ Bachelor’s degree in engineering (Chemical, Mechanical, Electrical, or related discipline) required.
▪ Advanced degree (MS or MBA) preferred.
Experience:
▪ 10+ years of engineering experience in Biotech, Pharma, or regulated life sciences.
▪ 5+ years of experience leading capital projects in a cGMP-regulated manufacturing environment.
▪ Demonstrated success delivering complex, cross-functional projects.
▪ Strong knowledge of pharmaceutical manufacturing processes (e.g., fractionation, bulk processing, fill/finish, packaging).
▪ Expertise in critical utilities and facilities systems (HVAC, WFI, clean steam, process gases).
▪ Familiarity with automation and control systems (e.g., PLC, SCADA).
▪ Deep understanding of commissioning, qualification, and validation (CQV) lifecycle.
▪ Strategic thinker with the ability to translate complex engineering challenges into actionable programs.
Competencies:
▪ Demonstrated ability to lead through influence and drive alignment across functions.
▪ Strong decision-making and problem-solving skills in complex environments.
▪ Excellent communication skills with the ability to engage effectively at all levels of the organization.
▪ Strategic mindset with strong execution discipline.
▪ Financial Acumen & ROI-oriented mindset
▪ Commitment to CSL values, ethical behavior, inclusive teamwork, and modeling a positive, respectful culture.
▪ PMP (Project Management Professional)
▪ Lean Six Sigma (Green Belt or higher)
▪ Professional Engineer (PE) license
The expected base salary range for this position at hiring is $173,000- $205,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Read Less