CQV Manager – Pharmaceutical

MMR Consulting; Greenville (SC); On-site; USD 120,000 - 180,000; Full time

Job summary

MMR Consulting is seeking a CQV Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects. You will oversee cross‑functional CQV execution across GMP facilities, utilities, equipment, automation, and processes while ensuring FDA and global regulatory compliance.

Travel to client sites throughout Raleigh, NC, will be required. The ideal candidate has 8+ years in pharma/biotech, 5+ years CQV PM experience in GMP environments, and

Qualifications

• 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.
• Experience authoring and reviewing validation lifecycle documentation.
• Strong experience leading cross‑functional teams and managing multiple project workstreams.

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 upstream/downstream bioprocess equipment, clean utilities, and fill-finish processes.
• Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards.
• Oversee execution of FAT/SAT, IQ/OQ/PQ protocols; Validation documentation; Deviations and CAPAs; Change controls.
• Collaborate with Quality Assurance, Engineering, Manufacturing, Automation, and Regulatory teams to support milestones.
• Manage third-party CQV consultants, contractors, and vendors.
• Provide risk assessments and mitigation strategies to maintain timelines and compliance.
• Support startup, operational readiness, and technology transfer activities.
• Present project status updates and KPI reporting to senior leadership.

Skills

Leadership

Cross-functional collaboration

Project management

Regulatory compliance

GMP knowledge

Education

Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline

Tools

Kneat

DeltaV

MES

SCADA

TrackWise

Veeva

Job description

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.

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: 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.

Required Experience

• 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: Cleanrooms; Process equipment; Utilities; Automation systems; 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.
• Background in biologics, sterile fill‑finish, vaccine, API, or aseptic manufacturing environments strongly preferred.

Required Qualifications

• 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; 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.

Compensation: Based on experience.

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.

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.