Validation Engineer - 174232

Piper Companies

Georgia

On-site

USD 135,000 - 155,000

Full time

6 days ago
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Job summary

Piper Companies seeks a Validation Engineer for a long-term contract at a leading pharmaceutical manufacturing site in Clayton, NC. The role focuses on executing validation protocols for aseptic fill-finish equipment, including filling isolators and Optima lines, with onsite work five days a week.

Responsibilities include supporting validation documentation, deviations, and change controls, and collaborating with QA, Engineering, and Manufacturing to ensure cGMP compliance and adherence to FDA

Qualifications

  • 7 years of validation experience in aseptic pharma manufacturing.
  • Experience with filling isolator equipment.
  • Experience with Optima filling lines.
  • Familiarity with TIMS (validation lifecycle management system).
  • 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 experience
IQ/OQ/PQ protocols
Regulatory compliance knowledge
Cross-functional collaboration

Tools

TIMS
Kneat

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

#ONSITE

This job is open for applications on 9/18/2026. Applications for this job will be accepted for at least 30 days from the posting date

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