Owner's Representative - CQV

PSC Biotech • Petersburg, VA

2d

About The Position

We are hiring an Owner’s Representative – CQV to join our team! In this role, you will serve as the client’s technical representative, overseeing and directing all commissioning, qualification, and validation (CQV) activities for large-scale capital projects. This position is highly technical in nature and demands advanced subject-matter expertise in CQV systems, sterile manufacturing processes, and operations within regulated environments.
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.

Requirements

• 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.

Nice To Haves

• Experience with ATEC systems preferred.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees