Validation Engineer - 177532

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 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.

The Validation Engineer role is a fully onsite position, requiring you to be onsite 5 days a week in Clayton, NC.

Responsibilities for the Validation Engineer Include:

• Execute validation protocols (IQ/OQ/PQ) for aseptic fill-finish equipment.
• Support validation documentation, deviations, and change controls.
• Collaborate with cross-functional teams including QA, Engineering, and Manufacturing.
• Ensure compliance with cGMP, FDA, and internal quality standards.

Requirements for the Validation Engineer Include:

• 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 similar to Kneat) is desirable.
• Strong understanding of regulatory requirements and validation best practices.

Compensation for the Validation Engineer Includes:

• Salary range: $135,000 - $155,000
• Comprehensive benefits: Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.

Key words: Validation, validation engineer, aseptic manufacturing, pharmaceutical manufacturing, fill finish, equipment validation, IQ/OQ/PQ Protocols, GMP compliance, FDA regulations, filling isolator equipment, optima filling lines, cleanroom validation, process validation, equipment qualification, validation lifecycle, TIMS, Kneat

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This job is open for applications on 10/30/2026. Applications for this job will be accepted for at least 30 days from the posting date