Jobs and Careers

Senior CQV Engineer

United Statesfull_timeVerifiedPosted 3 Sept 2025

About the role

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

Senior CQV Engineers are responsible for leading commissioning, qualification, and validation projects for pharmaceutical facilities, utilities, equipment, and systems. Our Senior CQV Engineers play a critical role in overseeing project planning, CQV execution, and ensuring the operational readiness of capital projects in order to support our clients’ success.

Drive project success by assessing priorities and project plans, schedule, and budget, and ensure timely and effective resolution of potential risks and issues.
Develop and execute commissioning, qualification, and validation protocols for required equipment and systems.
Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
Identify and assess risks associated with CQV activities and develop mitigation strategies.
Troubleshoot and resolve issues related to equipment and process performance.
Collaborative with cross-functional teams to ensure alignment of CQV activities and project timelines.
Serve as liaison between vendors and contractors, coordinating required hand-offs.
Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
Provide ongoing support and technical expertise through validation execution and qualification activities.
Additional responsibilities as required.

Requirements

Bachelor’s degree in engineering or a related field.
7+ years of commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
Experienced with laboratory equipment such as freezers and refrigerators, water generation skids, scales, etc.
Experienced in validating aseptic facilities, controlled temperature units, and EMPQ.
Experienced in validating facilities and utilities such as air compressors, boilers, chillers, clean steam generators, WFI, air handling units, etc.
Proven success in leading CQV projects and experience with project management methods and tools.
Experienced coordinating schedules, timelines, resources, and budgets.
Advanced knowledge of regulatory requirements and industry standards.
Experience with validation lifecycle management and risk-based approaches.
Expertise in full CQV project lifecycle execution from planning, initiation, execution, and closeout.
Excellent analytical and technical problem-solving skills. Ability to analyze