PHARMACEUTICAL – SR. CQV Manager/PM
About The Position
MMR Consulting is seeking a Sr. CQV Manager/PM with previous Pharmaceutical/Biotech experience (Commissioning, Qualification & Validation – Pharmaceutical Manufacturing) for a role that requires 90% travel to various locations including Denver/Boulder, Raleigh, the Midwest, Philadelphia, Portland, and Chicago. This is an opportunity to join a growing team of engineers involved in the design, commissioning & qualification, start-up, and project management of various processes, systems, and facilities within the pharmaceutical and biotechnology industries. The role involves leading teams of intermediate and junior engineers and overseeing commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives. The individual will manage cross-functional CQV execution for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes, ensuring compliance with FDA, cGMP, and global regulatory standards. Strong pharmaceutical project leadership experience in biotech, sterile manufacturing, fill-finish, API, or biologics environments is essential. The role serves as a key liaison between engineering, quality, validation, manufacturing, and external vendors, requiring management of project schedules, budgets, risks, resources, and validation deliverables for facility expansions, new product introductions, and operational readiness initiatives.
Requirements
- Minimum 8–12 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 Cleanrooms, Process equipment, Utilities, Automation systems, and Manufacturing processes.
- Experience 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.
- Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
- Strong understanding of cGMP regulations, FDA validation requirements, ISPE Baseline Guides (inc. C&Q) and ASTM E2500 GUIDE, and GAMP 5 principles.
- Proficiency 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.
Nice To Haves
- Background in biologics, sterile fill-finish, vaccine, API, or aseptic manufacturing environments strongly preferred.
- 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.
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 equipment, Clean utilities, HVAC systems, Automation and control systems, and Manufacturing and packaging lines.
- Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards.
- Oversee execution of FAT/SAT protocols, IQ/OQ/PQ protocols, Validation documentation, Deviations and CAPAs, and Change controls.
- Collaborate 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.
Benefits
- Equal Employment Opportunity and Reasonable Accommodations
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What This Job Offers
Job Type
Full-time
Career Level
Senior
