CQV Engineer
Listed on 2026-05-31
-
Engineering
Quality Engineering, Biomedical Engineer, Process Engineer
Overview
Saint Louis, United States | Posted on 05/19/2026
PSC Biotech is a life sciences services provider. We are hiring a motivated CQV Engineer I responsible for the commissioning, qualification, and validation of facilities, utilities, and equipment in the pharmaceutical and biotech industries. The engineer will support validation planning, development, documentation, and execution while ensuring regulatory standards and quality requirements are met.
Responsibilities- 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 effective mitigation strategies.
- 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 (Mechanical, Chemical, or related field) or Life Sciences.
- 1-3 years of validation experience within pharmaceutical, biotech, or medical device industries.
- Strong knowledge of equipment and process validation in FDA-regulated environments.
- Familiarity with industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations.
- Experience with cleanroom systems, HVAC, purified water, compressed air, and other critical utilities.
- Proficiency in writing and executing IQ/OQ/PQ protocols and validation reports.
- Strong analytical and problem‑solving skills.
- Excellent written and verbal communication abilities.
- Strong time management and organizational skills.
- Detail-oriented mindset with a commitment to maintaining high-quality standards.
- Must be authorized to work in the US.
- No C2C at this time.
- 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, 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.
PSC Biotech 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.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).