Onsite Aseptic Validation Engineer - Fill-Finish Expert

Piper Companies

Georgia

On-site

USD 135,000 - 155,000

Full time

9 days ago

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Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k

Paid time off

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 role, requiring you to be onsite 5 days a week in Clayton, NC. Responsibilities include executing IQ/OQ/PQ protocols, supporting validation documentation

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 (a 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 QA, Engineering, and Manufacturing.
Ensure compliance with cGMP, FDA, and internal quality standards.

Skills

Validation protocols experience (IQ/OQ

Aseptic pharma manufacturing

Filling isolator equipment

Optima filling lines

Regulatory compliance knowledge

Tools

TIMS

Job description

This is a fully onsite role, requiring you to be onsite 5 days a week in Clayton, NC. Responsibilities include executing IQ/OQ/PQ protocols, supporting validation documentation

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