CQV Engineer

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.

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

We strongly believe in coaching and developing the next generation of industry leaders and influencers. You will receive a compensation and benefits structure that rewards you, and the tools to grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

We are hiring CQV Engineers (I, II, III, IV) of varying experience to commission, qualify, and validate facilities, utilities, and process equipment in the pharmaceutical and biotech industries. Engineers play a critical role in driving project success, supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met.

• Develop, write, and execute IQ, OQ, PQ 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 effective mitigation strategies. Support deviation resolution, change control assessments, and CAPA activities.
• Troubleshoot and resolve issues related to equipment and process performance.
• Collaborate with cross‑functional teams to ensure alignment on CQV activities and project timelines.
• Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
• Additional responsibilities as required to drive successful validation project deliverables.

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Proven experience in equipment commissioning, qualification, and validation engineering in the pharmaceutical manufacturing industry.
• Strong knowledge of regulatory requirements and industry standards. Strong understanding of risk‑based validation and full lifecycle approach.
• Experience qualifying large process equipment and supporting utilities (vessels, CIP/SIP skids, isolators, autoclaves, WFI, clean steam, etc.). Cell and gene therapy experience preferred.
• Experience with paperless validation systems (e.g., Kneat).
• Excellent analytical and technical problem‑solving skills.
• Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications, and requirements).
• Effective communication and interpersonal skills.
• Proactive with strong organization, time management, and project management abilities.
• Excellent attention to detail with commitment to quality and compliance.
• Willingness and ability to travel as needed for project assignments and client engagements. Ability to adapt to different locations, cultures, and work environments.
• Must be authorized to work in the US.
• No C2C at this time.

W2 temporary positions include medical and sick time benefits.

PSC 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.