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Senior Validation Engineer
PSC BiotechUnited Statesfull_timeVerifiedPosted 6 Aug 2026
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
We are seeking an experienced Senior Validation Engineer to support commissioning, qualification, and validation activities for laboratory equipment, computerized systems, and analytical instrumentation within a regulated pharmaceutical or biotechnology environment. This individual will lead validation lifecycle activities, including protocol development, execution, deviation management, and final reporting, while ensuring compliance with cGMP, data integrity, and regulatory requirements.
- Lead and execute commissioning, qualification, and validation activities for laboratory equipment, analytical instruments, utilities, and computerized systems.
- Develop, review, and execute validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
- Author, execute, and review validation documentation within the KNEAT platform.
- Support Computer System Validation (CSV) activities.
- Perform risk assessments and apply risk-based validation methodologies throughout the system lifecycle.
- Collaborate with cross-functional stakeholders to ensure validation activities are executed on schedule and in compliance with site procedures.
- Support deviation investigations, CAPAs, change controls, and impact assessments associated with validation activities.
- Provide technical leadership and mentorship to junior validation engineers and project team members.
- Support internal audits, client audits, and regulatory inspections as needed.
- Ensure all validation documentation is complete, accurate, and inspection-ready.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Computer Science, or related technical discipline.
- Minimum 7+ years of validation, commissioning, qualification, or quality engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.
- Demonstrated experience with laboratory equipment qualification and analytical instrument validation.
- Strong Computer System Validation (CSV) experience supporting regulated computerized systems.
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