PSC Biotech® Corporation · 5 days ago
Owner's Representative - CQV
Petersburg, VA
Full-time
Hybrid
Senior Level, Lead/Staff
10+ years expPSC Biotech® Corporation provides essential services in the life sciences sector to ensure compliance with regulatory standards. The Owner’s Representative – CQV will oversee all commissioning, qualification, and validation activities for large-scale capital projects, ensuring adherence to GMP and FDA guidelines.
BiotechnologyConsultingLife ScienceProject ManagementQuality AssuranceRental
No H1B
Responsibilities
Act as the Owner’s Representative to lead, coordinate, and manage the full CQV program throughout the project lifecycle
Oversee and direct third-party validation engineers, ensuring alignment with project goals, technical standards, and regulatory expectations
Develop, maintain, and drive the CQV schedule, deliverables, and resource plans for complex capital projects
Provide technical direction and oversight for commissioning, qualification, and validation of sterile injectable equipment, utilities, and facility systems
Ensure all CQV activities strictly adhere to GMP, FDA, and global regulatory guidelines
Identify, assess, and mitigate technical and project risks to maintain project continuity and compliance
Work closely with engineering, quality, operations, and regulatory teams to ensure technical alignment across the project
Manage contractors and vendors responsible for equipment installation, testing, qualification, and documentation
Drive the implementation of CQV best practices, risk-based approaches, and industry standards within sterile or combination product environments
Qualification
Required
Bachelor's degree in Engineering or a related scientific discipline
Minimum 10 years of hands-on validation experience in GMP environments, including equipment, utilities, and process validation
Minimum 5 years of project management experience leading large-scale CQV capital projects
Demonstrated experience serving as an Owner's Representative or leading multi-disciplinary CQV programs
Strong technical background in sterile injectable or combination product manufacturing
Expertise in industry regulations, validation standards, and risk-based CQV methodologies
Proven ability to manage project schedules, budgets, and cross-functional teams
Exceptional analytical, problem-solving, and technical communication skills
Willingness to travel as required for project execution and client engagement
Must be authorized to work in the US
No C2C at this time
Preferred
Experience with ATEC systems
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
Funding
Current Stage
Growth StageLeadership Team
John Clapham
CEO
Recent News
2025-12-18
2025-10-20
Company data provided by crunchbase