Owner's Representative - CQV

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

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.
• Experience with ATEC systems preferred.
• Willingness to travel as required for project execution and client engagement.
• Must be authorized to work in the US.
• No C2C at this time.
  

Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• 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
  

Equal Opportunity Employment Statement:

PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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