Validation Engineer
Clayton, North Carolina
Job Id:
155649
Job Category:
Job Location:
Clayton, North Carolina
Security Clearance:
No Clearance
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Bailey Horne
Piper Companies is seeking a Validation Engineer for a long-term contract opportunity at a leading pharmaceutical manufacturing site in Clayton, NC. The Validation Engineer will support the execution of validation protocols for aseptic fill-finish equipment, ideally including filling isolators and Optima filling lines. The Validation Engineer role is a fully onsite position, requiring you to be onsite 5 days a week in Clayton, NC.
Responsibilities for the Validation Engineer Include:
· Execute validation protocols (IQ/OQ/PQ) for aseptic fill-finish equipment.
· Support validation documentation, deviations, and change controls.
· Collaborate with cross-functional teams including QA, Engineering, and Manufacturing.
· Ensure compliance with cGMP, FDA, and internal quality standards.
Requirements for the Validation Engineer Include:
· 2–5 years of validation experience in aseptic pharma manufacturing.
· Experience with filling isolator equipment is highly preferred.
· Experience with Optima filling lines is a strong plus.
· Familiarity with TIMS (a validation lifecycle management system similar to Kneat) is desirable.
· Strong understanding of regulatory requirements and validation best practices.
Compensation for the Validation Engineer Includes:
· Salary range: $100,000 - $135,000
· Comprehensive benefits: Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.
Key words: Validation, validation engineer, aseptic manufacturing, pharmaceutical manufacturing, fill finish, equipment validation, IQ/OQ/PQ Protocols, GMP compliance, FDA regulations, filling isolator equipment, optima filling lines, cleanroom validation, process validation, equipment qualification, validation lifecycle, TIMS, Kneat
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This job is open for applications on 12/1/2025. Applications for this job will be accepted for at least 30 days from the posting date