Senior Validation Engineer

PSC Biotech • Durham, NC

2d

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.

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.
• Hands-on experience using KNEAT for protocol development, execution, review, approval, and lifecycle management.
• Extensive knowledge of validation lifecycle activities, including: Risk Assessments, Validation Plans, IQ/OQ/PQ Execution, Traceability Management, Validation Reporting, Change Control, Deviation Management.
• Thorough understanding of cGMP regulations, FDA requirements, GAMP 5, 21 CFR Part 11, and data integrity principles.
• Strong technical writing and documentation skills.
• Ability to independently manage complex validation projects in a fast-paced environment.
• Excellent communication, stakeholder management, and cross-functional collaboration skills.
• Must be authorized to work in the U.S.
• No C2C at this time.

Nice To Haves

• Experience supporting regulatory inspections and audit readiness activities preferred.

Responsibilities

• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior