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PQA Engineer

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
38101
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PQA Engineer – North Carolina – Pharmaceuticals – Contract

Our client, a global pharmaceutical manufacturing organization are looking for a talented PQA Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Key Responsibilities:
  • Supports the development of documents, processes, and procedures.
  • Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Systems are first validated and then maintained in a validated state through startup and into commercial operation.
  • Provides oversight, review, and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, protocol deviations, validation plans, and validation summary reports.
  • Ensures project and operational quality objectives are met within desired timelines.
  • Participates in optimization or improvement initiatives and support regulatory agency and third party inspections.
Requirements:
  • BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable GMP industry experience.
  • Experience in Commissioning, Qualification, and Validation (CQV), Current Good Manufacturing Practices (cGMP) manufacturing operations and/or Quality oversight, in an Food and Drug Administration (FDA) regulated facility.
  • High level of familiarity/understanding of qualification / validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT systems, clean rooms, classified spaces, controlled temperature units (CTUs), Cleaning verification and validation, Clean in Place (CIP) / Steam in Place (SIP), and associated testing methodologies.
If this role is of interest, please apply now.

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