Validation Engineer
About The Position
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 Our Validation Engineers support the full system lifecycle management, ensuring analytical equipment and systems are implemented, validated, and maintained in compliance with FDA, EU, and global GxP regulations. This position plays a critical role in reducing compliance risks and enhancing operational performance while executing high-quality validation deliverables, providing technical expertise, and supporting regulatory readiness.
Requirements
- Degree in Engineering, Life Sciences, or a related discipline.
- 5+ years of proven CQV experience within GxP regulated manufacturing and operations environments.
- Well-versed in analytical equipment and systems commissiong, qualification, and validation activities and system lifecycle management.
- Strong understanding of risk-based validation.
- Well-versed in regulatory requirements and guidelines (FDA, EMA, ICH, cGMP, GAMP, etc.)
- Experienced with traceability, change control, deviation handling, and CAPA management.
- Excellent documentation and writing skills.
- Strong communication skills and ability to work with cross-functional teams.
- Advanced analytical skills with strong attention to detail and commitment to quality.
- Must be authorized to work in the US.
- No C2C at this time.
Responsibilities
- Execute CQV lifecycle activities for analytical equipment and systems.
- Develop and execute required lifecycle documentation and deliverables, including but not limited to plans, requirement specification, risk assessments, traceability matrices, IQ/OQ/PQ protocols, summary reports, and change control documentation.
- Analyze testing data, verify data, and monitor results. Provide effective data integrity oversight.
- Participate in deviation investigations, root cause analysis, change control management, CAPA implementation, and risk-based impact assessments.
- Support new technology implementation, collaborating with cross-functional teams to establish and define requirements, operational practices, reliability, and compliance risks.
- Additional responsibilities as required.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1-10 employees
