Validation & Engineering Group, Inc.
Commissioning & Qualification Lead – Upstream & Downstream Process Equipment LL0
Validation & Engineering Group, Inc., Juncos, Juncos, us, 00777
Commissioning & Qualification Lead – Upstream & Downstream Process Equipment LL05-250822
3 weeks ago Be among the first 25 applicants 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. Seniority Level
Mid‑Senior level Employment Type
Full‑time Job Function
Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x Get notified about new Lead jobs in
Juncos, Puerto Rico .
#J-18808-Ljbffr
3 weeks ago Be among the first 25 applicants 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. Seniority Level
Mid‑Senior level Employment Type
Full‑time Job Function
Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x Get notified about new Lead jobs in
Juncos, Puerto Rico .
#J-18808-Ljbffr