Onsite Validation Engineer: Aseptic Fill-Finish Expert

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

Benefits offered by this job

Medical

Dental

Vision

401k

PTO

Holidays

Job summary

Piper Companies seeks a Validation Engineer for a long-term contract at a leading pharmaceutical manufacturing site in Clayton, NC. This fully onsite role requires you to work onsite five days a week and lead IQ/OQ/PQ validation activities for aseptic fill-finish equipment.

The ideal candidate has 7+ years of aseptic validation experience, familiarity with filling isolator equipment and Optima lines, and knowledge of TIMS/Kneat systems to manage validation lifecycles.

Qualifications

• 7 years of validation experience in aseptic pharma manufacturing.
• Experience with IQ/OQ/PQ validation protocols.
• Strong understanding of regulatory requirements and GMP/FDA standards.
• Experience collaborating with QA, Engineering and Manufacturing teams.

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 to ensure compliance.
• Maintain alignment with cGMP, FDA and internal quality standards.

Skills

Aseptic GMP manufacturing

IQ/OQ/PQ validation protocols

Regulatory compliance

Cross-functional collaboration

Tools

TIMS

Kneat

Optima filling lines

Job description

Piper Companies seeks a Validation Engineer for a long-term contract at a leading pharmaceutical manufacturing site in Clayton, NC. This fully onsite role requires you to work onsite five days a week and lead IQ/OQ/PQ validation activities for aseptic fill-finish equipment.

The ideal candidate has 7+ years of aseptic validation experience, familiarity with filling isolator equipment and Optima lines, and knowledge of TIMS/Kneat systems to manage validation lifecycles.