Job Summary:
The Cleaning Validation Specialist will be responsible for developing, executing, and managing cleaning validation activities to ensure compliance with regulatory requirements and internal quality standards. The role focuses on ensuring the effectiveness and consistency of cleaning processes, particularly for manufacturing equipment and related systems, including utilities and compressed air systems. The ideal candidate will bring expertise in cleaning validation, utilities qualification, and a strong understanding of GMP regulations.
Responsibilities:
Develop and implement cleaning validation protocols and reports, ensuring compliance with GMP, FDA, and other regulatory standards.
Plan and execute cleaning validation activities for manufacturing equipment and utilities, including compressed air systems.
Conduct risk assessments and identify critical control points for cleaning validation.
Perform sampling and testing of cleaned equipment and utilities to ensure compliance with predetermined acceptance criteria.
Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to define cleaning validation requirements and processes.
Develop and implement protocols for utilities qualification and monitoring, with a focus on compressed air systems.
Analyze data to identify trends and recommend process improvements to enhance cleaning and utilities validation performance.
Manage deviations and non-conformances related to cleaning validation activities, ensuring timely investigation and resolution.
Maintain detailed and accurate documentation of cleaning validation and utilities qualification activities.
Ensure the consistent implementation of cleaning validation processes across manufacturing operations.
Support audits and inspections by regulatory authorities, providing expertise in cleaning validation and utilities processes.
Stay current with industry trends and regulatory updates, ensuring continuous compliance and the adoption of best practices.
Qualifications:
Bachelors Degree in Engineering, Chemistry, Microbiology, or a related field.
2+ years of experience in cleaning validation within a regulated manufacturing environment.
Experience in utilities qualification, particularly compressed air systems.
Strong knowledge of regulatory requirements, including GMP, FDA, and ICH guidelines.
Proficiency in developing and executing cleaning validation protocols and reports.
Demonstrated experience in risk assessment and data analysis for cleaning validation.
Excellent problem-solving and analytical skills.
Strong communication and interpersonal skills to collaborate with cross-functional teams and external auditors.
Proficiency in software tools such as MS Excel, Word, PowerPoint, and project management tools.
Physical/Mental Requirements:
Ability to work in a manufacturing environment, including cleanrooms and production areas.
Able to stand for extended periods and climb ladders/steps as needed.
Ability to lift and move items up to 25 lbs.
About the Company:
We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.
Overview:
The Automation Specialist III is directly responsible for the execution of all automation assignments to fulfill our clients operational and compliance needs. This role requires deep expertise in, with a focus on biotechnology processes, particularly in purification and utilities systems. The ideal candidate will apply advanced engineering principles to the design, implementation, and optimization of automation solutions for manufacturing environments regulated under cGMP standards.
Key Responsibilities:
Lead the execution of multiple, large-scale automation projects across various client sites.Coordinate and oversee the development, troubleshooting, and continuous improvement of automation systems in biotechnology purification and utility processes.Apply advanced knowledge of systems to optimize bioprocess control and performance.Provide day-to-day management and support of automation systems, including software/hardware integration.Troubleshoot and maintain manufacturing and utility equipment automation systems to ensure reliable operation.Design, develop, and optimize control logic for HMI, SCADA, and PLC systems.Perform inspections, testing, and commissioning of automated systems following SOPs and protocols.Prepare technical documentation, engineering analysis, and project status reports.Collaborate across departments to align automation strategies with overall process goals and regulatory requirements.Provide support for validation and qualification activities for automation systems in accordance with FDA and industry guidelines.Keep current with industry trends and incorporate best practices into automation strategies.Qualifications:
BS/BA degree in Engineering, Biotechnology, or a related technical field.Minimum of 6 years of experience in automation roles, with at least 3 years specifically working with DeltaV systems.Proven knowledge of biotech purification processes and utilities systems (e.g., clean steam, WFI, HVAC).Strong background in PLC, SCADA, and standalone systems in GMP-regulated environments.Basic project management knowledge: scheduling, timeline tracking, and milestone delivery.Experience with Microsoft-based systems, SQL, Visual Studio, and AutoCAD is preferred.Excellent interpersonal and communication skills for cross-functional collaboration.Self-motivated, organized, and capable of handling multiple tasks in a dynamic environment.Bilingual: English and Spanish (written and verbal proficiency required).Physical/Mental Requirements:
Ability to stand for extended periods during test runs.Capable of working extended shifts, as required.Ability to climb ladders and lift up to 25 lbs.Must wear required gowning and PPE in manufacturing and cleanroom areas to meet GMP and OSHA standards.Equal Employment Opportunity (EEO) Statement:
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.
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Overview:
The CSV Account & Project Manager is responsible for managing client accounts, developing new business opportunities, and overseeing project execution for Moriahs services. This role combines technical project leadership with client service excellence, ensuring projects are delivered on time, on budget, and in compliance with all applicable standards, particularly in regulated industries such as pharmaceuticals and medical devices.
Responsibilities
Serve as primary point of contact for assigned clients, maintaining strong, long-term
relationships.
Identify areas of service (sales) opportunity & develop proposal.
Supervise, coach and lead the department team for overall projects and department
objectives.
Coordinate with Project Lead Coordinators to manage timelines, deliverables, and
resources.
Partner with upper management to develop strategies for business development
growth.
Identify areas of opportunity to expand services and support proposal development.
Act as technical consultant for automation and CSV solutions, providing strategic
recommendations to clients.
Lead and supervise cross-functional project teams in planning and execution.
Promote team engagement, accountability, and high performance throughout
project execution.
Conduct performance evaluations, one-on-one meetings, and approve PTO.
Ensure that all projects meet compliance standards (e.g., FDA, GMP) and client
expectations.
Maintain strong internal communication with operations and leadership teams.
Qualifications
Bachelors Degree Engineering, science or related field.
Ability to plan, manage and execute complex project activities to a successful
conclusion with little or no oversight.
5+ years of experience in engineering consulting, project management, or client
facing technical roles.
Proven experience in account management, sales, or consultative sales within
technical or regulated industries.
Experience with network and system administration of Microsoft based systems,
Visual Studio, ASP.Net and SQL is preferred.
Demonstrated successful communication and negotiation skills in order to manage
conflicting and/or multiple demands, including ability to present to various level
within an organization.
Demonstrated ability to apply analytical skills to identify problems; recognizes
symptoms, causes, and alternate solutions and makes timely sound decisions even
under risk and uncertainty.
Strong understanding of automation systems, PLCs, CSV, and related validation
frameworks.
Proven experience in CSV execution projects.
Proven track record in business development within the pharmaceutical or
regulated industries.
Skilled in managing multiple projects, teams, and priorities in parallel.
Proficiency in project management and CRM software.
Bilingual (Spanish and English) preferred.
Physical/Manufacturing Requirements
Office and plant environment.
Able to climb/ ladders/steps
Able to lift items 25 lbs
Keyboarding, lifting, standing, bending, walking.
Travel or Environment Requirements
Adhere to safe work practices
Some travel (including international) required (Approx. 5% of time)
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.
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