Commissioning & Qualification Lead – Upstream & Downstream Process Equipment LL05-250822 jobs in United States
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Validation & Engineering Group, Inc. · 4 months ago

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

positionJuncos, 077
timeFull-time
remoteOnsite
senioritySenior Level
date7+ years exp

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries including Pharmaceutical and Biotechnology. The CQV Lead will oversee all commissioning, qualification, and validation activities related to upstream and downstream process equipment in a biotech GMP manufacturing facility, ensuring compliance and project delivery.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

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
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
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

Qualification

CQV experienceBiotech process knowledgeGMP documentationElectronic validation platformsAutomation familiarityLeadership experienceCoordination skillsCommunication skillsProblem-solving skills

Required

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

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

Company

Validation & Engineering Group, Inc.

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Validation & Engineering Group, Proudly serving our clients since 1997.
dateFounded in 1997
location
Guaynabo, NA - Puerto Rico, PRI
people-size51-200 employees
web-link
http://veg-group.com/

Funding

Current Stage
Growth Stage
Total Funding
unknown
2025-08-06Acquired

Leadership Team

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Luis Puig
Partner
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Recent News

News is my Business
Pinnaql buys Validation & Engineering Group to boost life sciences reach
2025-08-20
PR Newswire
Pinnaql Acquires VEG, Broadening Manufacturing Compliance & Quality Services Platform
2025-08-06
Company data provided by crunchbase