CQV Project Manager

Job Description

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 a Senior CQV Project Manager to deliver comprehensive support throughout every stage of the CQV lifecycle. This role offers expert guidance in project planning, strategic development, and execution, employing a risk-based methodology to ensure adherence to regulatory standards and the highest levels of product safety.

• Lead and manage CQV engineers and contractors throughout project execution.
• Oversee commissioning and startup of new equipment, utilities, and cleanroom systems.
• Develop and approve IQ / OQ / PQ protocols for newly installed systems and equipment.
• Prepare, review, and maintain documentation, including validation protocols, plans, reports, and SOPs.
• Support risk assessments and mitigation strategies related to CQV activities.
• Ensure timely execution of PPQ testing and validation deliverables.
• Coordinate with vendors and contractors to support hand-offs and system turnover.
• Ensure compliance with regulatory requirements (FDA, EMA) and industry standards (GMP, GAMP).
• Provide technical oversight during validation execution and qualification activities.
• Additional responsibilities as required .

Requirements

Benefits

Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $120,000 – $140,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

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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