Onsite Validation Engineer: Aseptic Fill-Finish

Piper Companies; Georgia; On-site; USD 135,000 - 155,000; Full time

Job summary

Piper Companies seeks a Validation Engineer for a long-term contract at a leading pharmaceutical manufacturing site in Clayton, NC. The role focuses on executing validation protocols for aseptic fill-finish equipment, including filling isolators and Optima lines, with onsite work five days a week.

Responsibilities include supporting validation documentation, deviations, and change controls, and collaborating with QA, Engineering, and Manufacturing to ensure cGMP compliance and adherence to FDA

Qualifications

• 7 years of validation experience in aseptic pharma manufacturing.
• Experience with filling isolator equipment.
• Experience with Optima filling lines.
• Familiarity with TIMS (validation lifecycle management system).
• 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 QA, Engineering, and Manufacturing.
• Ensure compliance with cGMP, FDA, and internal quality standards.

Skills

Validation experience

IQ/OQ/PQ protocols

Regulatory compliance knowledge

Cross-functional collaboration

Tools

TIMS

Kneat

Job description

Piper Companies seeks a Validation Engineer for a long-term contract at a leading pharmaceutical manufacturing site in Clayton, NC. The role focuses on executing validation protocols for aseptic fill-finish equipment, including filling isolators and Optima lines, with onsite work five days a week.

Responsibilities include supporting validation documentation, deviations, and change controls, and collaborating with QA, Engineering, and Manufacturing to ensure cGMP compliance and adherence to FDA