Validation Engineer

Your Role

The Validation Engineer supports system validation activities within regulated manufacturing environments. The role works closely with cross-functional teams to ensure automation software and manufacturing equipment/systems are implemented, tested, validated, and maintained in compliance with regulatory standards. The role will play a key part in supporting system lifecycle activities, with a strong emphasis on documentation, compliance, and data integrity.

Responsibilities

• Support the validation lifecycle for automation and computerized systems, including development, review, and execution of validation deliverables.
• Partner with Engineering, Quality, IT, and external vendors to ensure systems are implemented and maintained in alignment with regulatory and internal standards.
• Assist in the configuration, testing, and troubleshooting of automation and manufacturing-related software applications.
• Evaluate system changes and support change control activities, including impact assessments and associated documentation updates.
• Ensure systems meet data integrity and electronic records/electronic signature requirements (e.g., 21 CFR Part 11).
• Support integration and data flow between manufacturing systems (e.g., equipment automation, MES/OMS platforms) to ensure reliable and accurate system performance.
• Review and approve technical and validation documentation to ensure completeness, accuracy, and compliance with cGMP requirements.
• Additional related responsibilities as required.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related discipline.
• Minimum of 3 years of experience in computerized system validation, automation software, and manufacturing systems within regulated life science industries (i.e. pharma, biotech).
• Well-versed in manufacturing systems, including automation platforms, control systems, and MES/OMS applications.
• Strong knowledge of cGMP requirements and validation frameworks (e.g., Part 11 Compliance, GAMP 5).
• Experience with validation documentation, including protocol development, execution, and traceability.
• Strong technical troubleshooting and analytical skills.
• Excellent written and verbal communication skills, with the ability to collaborate across functional teams.
• Must be authorized to work in the U.S.
• No C2C at this time.

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, Short/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.