CQV Manager – Pharmaceutical

Previous Pharmaceutical/Biotech experience is mandatory for this role

(Commissioning, Qualification & Validation – Pharmaceutical Manufacturing)

The work will require travel to work at client sites throughout Raleigh, NC, US.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.

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 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 for a CQV Manager will 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.

• 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:
  Upstream Bioprocess Equipment (Bioreactors, Fermantation, Centrifugation, etc…), Downstream Bioprocess Equipment (Chromatography, TFF, etc..), General Process Systems (Buffers, Media, CIP, Tanks, Washing & Sterilization, Etc..), Clean Utilities (WFI, PW, etc..), Fill Finish (Aseptic Fill, Isolators).
• 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;
  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.

• Minimum 8+ years of experience in pharmaceutical, biotech, or life sciences industries.
• Minimum 5 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:
  Clean rooms;
  Process equipment;
  Utilities;
  Automation systems;
  Manufacturing processes.
• Experience authoring and reviewing validation lifecycle documentation.
• Demonstrated success leading cross‑functional teams and managing multiple project work streams simultaneously.
• Experience supporting FDA audits and regulatory inspections.
• Background in biologics, sterile fill‑finish, vaccine,…