Validation Engineer - 174232 - 174720 - 175228 - 175694 - 176144

Piper Companies; Clayton (NC); Vor Ort; USD 135.000 - 155.000; Vollzeit

Zusammenfassung

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 position, requiring you to be onsite 5 days a week in Clayton, NC.

Qualifikationen

• 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 (validation lifecycle management system) is desirable.
• Strong understanding of regulatory requirements and validation best practices.

Aufgaben

• 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.

Kenntnisse

Aseptic validation

IQ/OQ/PQ

Regulatory compliance

Cross-functional collaboration

Tools

TIMS

Kneat

Optima lines

Jobbeschreibung

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 10/16/2026. Applications for this job will be accepted for at least 30 days from the posting date