PSC Biotech® Corporation · 2 days ago
CQV Workstream Lead - Project Manager
United States
Full-time
Remote
Senior Level, Lead/Staff
10+ years expPSC Biotech® Corporation provides essential services to the life sciences sector, ensuring compliance in healthcare product development and distribution. The CQV Workstream Lead will oversee commissioning, qualification, and validation activities for a major biopharmaceutical manufacturing expansion project, providing strategic leadership across multiple systems to ensure regulatory and operational readiness.
BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
Responsibilities
Lead all CQV workstream activities across facilities, utilities, equipment, and manufacturing systems for a large‐scale biopharmaceutical expansion project
Develop, manage, and execute CQV strategy, schedules, deliverables, and resource plans in alignment with project objectives and regulatory expectations
Oversee commissioning and qualification of biopharmaceutical process equipment, including tanks/vessels, CIP skids, etc
Apply risk‑based CQV methodologies and ensure compliance with GMP, FDA, EMA, and global regulatory requirements
Lead and coordinate cross‑functional teams—including engineering, operations, quality, and automation—and provide technical direction to validation personnel and vendors
Ensure that all CQV documentation (URS, FAT/SAT support, IV/OV/PQ, risk assessments, protocols, reports) is generated, reviewed, and approved
Utilize KNEAT or similar systems for electronic validation lifecycle management
Identify project risks, develop mitigation strategies, and drive resolution of technical or schedule barriers
Provide ongoing communication to project leadership and stakeholders regarding progress, challenges, and readiness milestones
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
10+ years of commissioning, qualification, and validation experience in GMP biopharmaceutical environments
Hands‑on experience with bulk manufacturing processes and associated equipment
Demonstrated background in cleaning circuits, cleaning validation, and CIP lifecycle development
Strong leadership and project‑management capabilities managing complex, multi‑workstream CQV programs
Experience with risk‑based CQV approaches and electronic validation systems such as KNEAT
Excellent communication, stakeholder‑management, and technical problem‑solving skills
Must be authorized to work in the U.S
Ability and willingness to travel/work fully onsite as the project progresses
Benefits
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Company
PSC Biotech® Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
201-500 employees
H1B Sponsorship
PSC Biotech® Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (9)
2023 (3)
2022 (5)
2021 (5)
2020 (2)
Funding
Current Stage
Growth StageLeadership Team
John Clapham
CEO
Recent News
2025-12-18
2025-10-20
Company data provided by crunchbase