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

Job Description

Job Description

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.

Key Responsibilities :

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.

Equipment in Scope : 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

Qualifications :

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.

Preferred Experience :

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.