Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV.
MMR Consulting has offices in Canada, USA, and Australia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in project management, commissioning and qualification, of equipment, systems and facilities.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities. The work will require working out of clients facilities.
The work will require working on-site at clients facilities, which are located in US. Travel is required to US is required.
Responsibilities
Provide technical guidance into the assessments, design, project management, commissioning and start-up of equipment and facilities, for upgrades, renovations and expansions of client facilities and processes.Prepare business cases, with project purpose, risks, budget, schedule, resource requirements.Manage other design firms, equipment vendors, construction firms and internal / external stakeholders as required to execute projects.Manage Capital ProjectsLead or support project execution from feasibility through to project completion/handover, including all project stages such as:Feasibility Assessments
Concept Design, Basic Design, Detailed Design
Procurement
Construction / Installation
Project Controls - Monitoring
Commissioning & Qualification
Qualifications
Salary range: 110,000$ -150,000$ based on experience.
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
Previous Pharmaceutical/Biotech experience is mandatory for this role
(Commissioning, Qualification & Validation Pharmaceutical Manufacturing)
The work will require 90% travel to work in Denver/Boulder, Raleigh, midwest, Philadelphia, Portland, Chicago or other locations.
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.
MMRConsulting hasofficesinCanada,USA,andAustralia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning& qualification, start-up and project management of various processes, systems, and facilities.The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
This role is forSr. CQV Manager/PMwill require to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives. This individual will oversee cross-functional CQV execution for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes while ensuring compliance with FDA, cGMP, and global regulatory standards.
The ideal candidate will possess strong pharmaceutical project leadership experience within biotech, sterile manufacturing, fill-finish, API, or biologics environments and will serve as a key liaison between engineering, quality, validation, manufacturing, and external vendors. This role requires the ability to manage project schedules, budgets, risks, resources, and validation deliverables in support of facility expansions, new product introductions, and operational readiness initiatives.
Key Responsibilities
Lead all CQV project activities for pharmaceutical and biotech manufacturing projects.Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation.Coordinate commissioning and qualification activities for:Process equipmentClean utilitiesHVAC systemsAutomation and control systemsManufacturing and packaging linesEnsure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards.Oversee execution of:FAT/SAT protocolsIQ/OQ/PQ protocolsValidation documentationDeviations and CAPAsChange controlsCollaborate with Quality Assurance, Engineering, Manufacturing, Automation, and Regulatory teams to support project milestones and inspection readiness.Manage third-party CQV consultants, contractors, and vendors.Provide risk assessments and mitigation strategies to maintain project timelines and compliance objectives.Support startup, operational readiness, and technology transfer activities.Present project status updates and KPI reporting to senior leadership and stakeholders.Required Experience
Minimum 812 years of experience in pharmaceutical, biotech, or life sciences industries.Minimum 5 years of direct CQV project management experience within GMP-regulated manufacturing environments.Proven experience managing large-scale capital projects, facility expansions, or greenfield startup projects.Strong experience with commissioning and qualification of:CleanroomsProcess equipmentUtilitiesAutomation systemsManufacturing processesExperience authoring and reviewing validation lifecycle documentation.Demonstrated success leading cross-functional teams and managing multiple project workstreams simultaneously.Experience supporting FDA audits and regulatory inspections.Background in biologics, sterile fill-finish, vaccine, API, or aseptic manufacturing environments strongly preferred.Required Qualifications
Bachelors degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.Strong understanding of:cGMP regulationsFDA validation requirementsISPE Baseline Guides (inc. C&Q) and ASTM E2500 GUIDEGAMP 5 principlesProficiency with project management methodologies, scheduling tools, and reporting systems.Excellent communication, leadership, and stakeholder management skills.Ability to work effectively in fast-paced, highly regulated project environments.Preferred Qualifications
Digital Validation software experience (i.e. Kneat or equivalent)PMP certification preferred.Experience with DeltaV, MES, SCADA, or other pharmaceutical automation platforms.Familiarity with Kneat, TrackWise, Veeva, or electronic validation systems.Previous consulting or EPCM experience is a plus.Lean Six Sigma certification preferred.Compensation:120,000$-150,000$basedonexperience.
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
Previous Pharmaceutical/Biotech experience is mandatory for this role
MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.
MMRConsulting hasofficesinCanada,USA,andAustralia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning& qualification, start-up and project management of various processes, systems, and facilities.The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
This role is forSr. CQV Engineerwill require to work on the validation of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
The work will require working on-site at clients facilities, which are located in US. Travel is required to US is required.
Responsibilities
Provide technical guidance in the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities.Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle.Able to perform field execution of qualification test cases and protocols.Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following Process equipment, clean utilities, automation systems, laboratory equipment, building & facilitiesCoordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, and provide updates.Engage other departments, as required, in the design reviews and decisions.Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification, and validation phases.Visit construction and installation sites, wearing necessary safety PPE.You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.Supervise contractors during critical testing of system and equipment.Other duties as assigned by client, and/or MMR, based on workload and project requirements.As this position requires working on client sites, you will need to comply with the clients safety rules including mandatory vaccination policies for COVID-19, where applicableLead/Mentor a team of validation engineers/specialists.Qualifications
12+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for cGMP operations.Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required.Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset.Experience with commissioning and qualifications of biotech process equipment, such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), CIP systems, Buffer systems, Clean Utilities would be an asset.Experience with Qualification or Validation of clean utilities and ISO clean rooms.Experience with preparation and execution of URSs, DQs, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQsLead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset but not required.Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexities.Possess mentorship skills, to coach and develop junior and intermediate employees.Engineering degree, preferably in Mechanical, Electrical or Chemical.Travel may be required on occasion.Ability to handle multiple projects and work in a fast-paced environment.Strong multi-tasking skillsAbilitytolift50lbs.Compensation: 100,000$ - 115,000$ based on experience.
Equal Employment Opportunity and Reasonable Accommodations
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
