Validation Engineer - 174232 - 174720 - 175228

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 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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