Job Description
Job DescriptionA 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
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