Job DescriptionYour RoleWe 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.
- 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.
- Experience supporting regulatory inspections and audit readiness activities preferred.
- Must be authorized to work in the U.S. No C2C at this time.
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- 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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