Validation Engineer

Piper Companies is seeking a Validation Engineer for a globally recognized biologics company. This Validation Engineer will be supporting validation protocol execution in a cutting‑edge aseptic pharmaceutical manufacturing environment. This is a fully on‑site position in Clayton, NC.

• 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.

• 2–5 years of hands‑on validation experience in aseptic pharmaceutical manufacturing environments, with a strong understanding of GMP and regulatory compliance.
• Experience with filling isolator equipment is highly preferred; familiarity with Optima filling lines is a significant advantage.
• Proficiency in TIMS (Tracking and Information Management System) or similar validation documentation platforms (e.g., Kneat) is desirable.
• Must be able to work on‑site at our facility five days a week.

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

/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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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.