Jobs · Quality Assurance · North Carolina

Validation Engineer - 174232 - 174720 - 175228 - 175694

Piper Companies · Clayton, NC · 1 wk ago
Quality Assurance$135k–$155k/yrFull-time

About the role

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

  • 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

  • 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.

Benefits

  • Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.

Pay

Salary range: $135,000 - $155,000

Schedule

Fully onsite, 5 days per week in Clayton, NC.

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