Aseptic Fill-Finish Validation Engineer – Onsite Clayton

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k

Paid time off

Holidays

Sick leave

Job summary

Piper Companies is seeking a Validation Engineer for a long-term contract at a leading pharmaceutical manufacturing site in Clayton, NC. The role requires onsite work five days a week to support validation of aseptic fill-finish equipment, including filling isolators and Optima lines.

The candidate will execute IQ/OQ/PQ protocols, contribute to validation documentation, and ensure compliance with cGMP, FDA, and internal quality standards. Experience with TIMS is desirable.

Qualifications

• 7 years of validation experience in aseptic pharma manufacturing.
• Strong understanding of regulatory requirements and validation best practices.
• Experience with aseptic fill-finish validation is essential.

Responsibilities

• Execute IQ/OQ/PQ validation protocols for aseptic fill-finish equipment.
• Support validation documentation, deviations and change controls.
• Collaborate with QA, Engineering, and Manufacturing to ensure compliance with cGMP and FDA requirements.

Skills

Validation

Regulatory compliance

Aseptic pharma

Tools

TIMS

Kneat

Optima filling lines

Job description

Piper Companies is seeking a Validation Engineer for a long-term contract at a leading pharmaceutical manufacturing site in Clayton, NC. The role requires onsite work five days a week to support validation of aseptic fill-finish equipment, including filling isolators and Optima lines.

The candidate will execute IQ/OQ/PQ protocols, contribute to validation documentation, and ensure compliance with cGMP, FDA, and internal quality standards. Experience with TIMS is desirable.