Validation Engineer

Piper Companies is seeking a Validation Engineer for a globally recognized biologics company. This Validation Engineer will be involved in hands-on execution of validation protocols on aseptic fill lines. This is a fully on-site position in Clayton, NC.

Responsibilities of the Validation Engineer:

• Execute validation protocols on aseptic fill finish lines.
• Draft, review, and execute IQ/OQ/PQ protocols for aseptic filling isolators and Optima filling lines.
• Perform qualification of filling isolator systems, including environmental monitoring and smoke studies.
• Prepare and maintain validation documentation in TIMS.

Qualifications for the Validation Engineer:

• 2-5 years of validation experience in aseptic environments.
• Experience with aseptic fill lines strongly preferred (Optima experience is a plus).
• Prior experience in biologics/pharmaceutical manufacturing.
• Bachelor's degree in engineering or related.

Compensation for the Validation Engineer:

• Salary Range: $114,000-128,000/year
• Comprehensive Benefits: Sick leave if required by law, medical, dental, vision, 401K

This job opens for applications on 11/07/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: Validation, aseptic fill lines, fill finish, validation protocols, optima, optima fill lines, IQ/OQ/PQ, filling isolator system, smoke studies, biologics, manufacturing, TIMS, execute, isolator, aseptic, documentation, GMP, protocols, validation engineer, CQV engineer, filling line qualification engineer, process validation, CQV, manufacturing systems validation specialist.

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