Commissioning & Qualification Lead – Upstream & Downstream Process Equipment LL05-250822

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

CQV Lead – Upstream & Downstream Biotech Process Equipment

The CQV Lead will be responsible for overseeing all commissioning, qualification, and validation activities related to upstream and downstream process equipment in a biotech GMP manufacturing facility. This includes strategic planning, resource coordination, protocol development, execution oversight, and stakeholder engagement across the CQV lifecycle. The role requires a strong technical background in cell culture and purification systems, as well as leadership experience in cross-functional environments supporting project delivery, regulatory compliance, and schedule milestones.

Leadership & Project Management

• Lead CQV efforts for upstream and downstream equipment, ensuring alignment with overall project schedule and quality standards.
• Manage CQV engineers and contractors; assign responsibilities and oversee protocol development and execution activities.
• Represent CQV function in cross-functional meetings with QA, Manufacturing, Automation, Process Engineering, and Project Controls.
• Develop CQV strategy, work plans, and schedules in alignment with URS, risk assessments, and cGMP expectations.
• Support the resolution of deviations, non-conformances, and issues identified during commissioning and qualification.

Documentation & Execution Oversight

• Oversee the preparation and approval of commissioning plans, IQ/OQ/PQ protocols, risk assessments, and summary reports.
• Ensure traceability from URS to qualification deliverables (RTM).
• Approve system walkdowns, punchlist resolutions, and impact assessments.
• Lead or support FAT/SAT coordination and vendor engagements.

Compliance & Quality Assurance

• Ensure CQV activities are conducted in accordance with FDA, EMA, ICH Q8–Q10, ISPE Baseline Guide Vol. 5, and ASTM E2500.
• Collaborate with QA to ensure timely approvals of protocols and reports.
• Ensure all validation deliverables support readiness for regulatory inspections and PPQ readiness.

Upstream Systems:

• Bioreactors (single-use and stainless steel)
• Media preparation systems and skids
• Cell culture support equipment (incubators, mixing tanks)
• Control systems for pH, DO, temperature, agitation
• Seed train and expansion systems

Downstream Systems:

• Chromatography systems (Protein A, IEX, etc.)
• Tangential flow filtration (TFF) skids
• Virus filtration/inactivation systems
• Centrifuges and depth filtration units
• Bulk hold tanks and transfer skids
• CIP/SIP systems interfacing with both upstream and downstream trains

• Bachelor's or Master's degree in Engineering, Biotechnology, or related Life Sciences field.
• Minimum 7–10 years of CQV experience in GMP biopharmaceutical manufacturing.
• Demonstrated experience leading CQV teams in facility startups, tech transfers, or capital projects.
• Strong technical knowledge of both upstream (cell culture) and downstream (purification) processes.
• In-depth understanding of validation lifecycle and GMP documentation.
• Excellent communication, coordination, and problem-solving skills.

• Use of electronic validation platforms (e.g., Kneat, Valgenesis).
• Familiarity with DeltaV, Rockwell, or Siemens PCS automation.
• Previous experience on large-scale biotech capital projects (greenfield/brownfield).
• Experience interfacing with Quality Assurance and regulatory auditors.