Validation Engineer

Piper Companies is seeking a Validation Engineer to join a globally recognized biologics organization. This role involves hands-on execution of validation protocols for aseptic fill finish lines in a dynamic, GMP-compliant environment.

Responsibilities

• 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 activities for filling isolator systems, including environmental monitoring and smoke studies.
• Prepare and maintain validation documentation within TIMS.

Qualifications

• 2–5 years of validation experience in aseptic environments.
• Strong preference for experience with aseptic fill lines (Optima experience is a plus).
• Background in biologics or pharmaceutical manufacturing.
• Bachelor’s degree in engineering or a related field.

Compensation & Benefits

• Salary: $114,000–$128,000 annually.
• Comprehensive benefits package including medical, dental, vision, 401(k), and sick leave (as required by law).

Application Window: Opens 11/10/2025 and will remain open for at least 30 days.

Keywords: Validation, aseptic fill lines, fill finish, validation protocols, Optima, IQ/OQ/PQ, filling isolator systems, smoke studies, biologics, GMP, TIMS, documentation, pharmaceutical manufacturing.

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