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 insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Holidays and sick leave as required

Job summary

Piper Companies seeks a Validation Engineer for a long-term contract at a leading pharmaceutical manufacturing site in Clayton, NC. The role is fully onsite, requiring you to be on site 5 days a week in Clayton, NC.

You will execute IQ/OQ/PQ validation for aseptic fill-finish equipment, support validation documentation and change controls, and collaborate with QA, Engineering, and Manufacturing to ensure GMP compliance and FDA standards.

Qualifications

• 7 years of validation experience in aseptic pharma manufacturing.
• Strong understanding of regulatory requirements and validation best practices.
• Experience with filling isolator equipment is highly preferred.

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.

Skills

7+ years validation experience

cGMP/FDA knowledge

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. The role is fully onsite, requiring you to be on site 5 days a week in Clayton, NC.

You will execute IQ/OQ/PQ validation for aseptic fill-finish equipment, support validation documentation and change controls, and collaborate with QA, Engineering, and Manufacturing to ensure GMP compliance and FDA standards.