Validation Specialist

Synerfac Inc; Morrisville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Synerfac Inc. is seeking a Validation Specialist for a multi-year project portfolio at its Clayton, NC site.

The contract role (24 months, with potential extension) will lead validation across several projects, aligned to expertise in aseptic filling, device assembly and packaging, automation, facility systems, warehouse, and QC. The role requires 5+ years CQV experience, hands-on validation documentation, and strong GMP/FDA knowledge.

Qualifications

• 5+ years CQV experience required.
• Hands-on experience authoring and executing validation documentation.
• Solid understanding of GMP, FDA requirements, EU Annex 15, and GAMP 5.

Responsibilities

• Lead validation for multiple assigned projects, covering the full lifecycle from requirements through decommissioning.
• Develop and maintain validation plans and reports, specifications, risk assessments, and traceability matrices.
• Write, execute, and report on DQ, IQ, OQ, PQ, and process validation activities.
• Support commissioning and qualification so systems are ready for execution, including attending FAT when needed.
• Investigate and document deviations and engineering changes that come up during testing.
• Initiate or support change controls and evaluate their impact on validated systems.
• Create and route validation records in electronic systems such as HP ALM or Veeva.
• Keep project managers informed on status, risks, and escalations, and lead focused working sessions when needed.
• Partner with IT validation resources on computerized system projects.

Skills

CQV experience

GMP knowledge

FDA/regulatory familiarity

Job description

A pharmaceutical manufacturing company is seeking a Validation Specialist to support a multi-year project portfolio at its site in the Clayton, NC area. This is a 24 month contract with potential to extend. Each specialist will lead validation on several projects at once, matched to their background in areas such as aseptic filling, device assembly and packaging, automation, facility systems, warehouse, and QC.

Validation Specialist Responsibilities:

• -Lead validation for multiple assigned projects, covering the full lifecycle from requirements through decommissioning
• -Develop and maintain validation plans and reports, specifications, risk assessments, and traceability matrices
• -Write, execute, and report on DQ, IQ, OQ, PQ, and process validation activities
• -Support commissioning and qualification so systems are ready for execution, including attending FAT when needed
• -Investigate and document deviations and engineering changes that come up during testing
• -Initiate or support change controls and evaluate their impact on validated systems
• -Create and route validation records in electronic systems such as HP ALM or Veeva
• -Keep project managers informed on status, risks, and escalations, and lead focused working sessions when needed
• -Partner with IT validation resources on computerized system projects

Job Requirements

Validation Specialist Requirements:

• -5+ years of Commissioning, Qualification, and Validation (CQV) experience
• - Pharmaceutical experience is a plus
• -Hands-on experience authoring and executing validation documentation, including electronic validation
• -Solid understanding of GMP, FDA requirements, EU Annex 15, and GAMP 5