PQA Engineer
Posted 7 days ago by 1756284478
Negotiable
Undetermined
Undetermined
North America, East Coast
Summary: The PQA Engineer role is a contract position within a global pharmaceutical manufacturing organization located in North Carolina. The position involves supporting the development of processes and documentation, ensuring compliance with quality objectives, and participating in regulatory inspections. This is an opportunity to contribute to a 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.
Key Skills:
- 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.
Salary (Rate): undetermined
City: undetermined
Country: undetermined
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Pharmaceuticals
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.
- 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.
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