Onsite Aseptic Validation Engineer Fill-Finish Expert

Piper Companies; Clayton (NC); On-site; USD 135,000 - 155,000; Full time

Job summary

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.

This is a fully onsite position, requiring you to be onsite 5 days a week in Clayton, NC.

Qualifications

• 7 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 (validation lifecycle management system) is desirable.
• Strong understanding of regulatory requirements and validation best practices.

Responsibilities

• 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.

Skills

Aseptic validation

IQ/OQ/PQ

Regulatory compliance

Cross-functional collaboration

Tools

TIMS

Kneat

Optima lines

Job description

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.

This is a fully onsite position, requiring you to be onsite 5 days a week in Clayton, NC.