QA Validation Engineer

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Job type
Contract
Location
North Carolina, United States
salary
Competitive
Ref. No
39054
QA Validation Engineer - North Carolina, United States - 9-months contract

Our client works across regulated sectors to build robust, repeatable compliance and validation practices. They prioritise clear guidance, clean documentation, and controls that fit how teams operate.
 

What you’ll do:

  • The QA Validation Specialist is responsible for implementing, executing, and assessing quality systems, procedures, and records to support compliant GMP operations.
  • The role works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation teams.
  • Provide hands‑on QA support and oversight to internal teams and suppliers/contractors to ensure compliance with applicable quality standards, regulatory requirements, and industry guidance.
  • Review and approve commissioning, qualification, and validation documentation.
  • Review and approve qualification and validation deviations and discrepancies, supporting investigation and corrective actions.
  • Work collaboratively across site functions to instil a strong quality culture, coaching in the application of GMP principles and the rationale behind them.
  • Author, review, and approve controlled documents for Quality and other GMP functions, including SOPs, specifications, protocols, and reports.
  • Assist in the preparation for, and hosting of, regulatory inspections and audits as required.

What you’ll need:

  • Degree in biological, physical or chemical sciences, engineering, or a related field, with  experience in QA within biologics manufacturing. 
  • Strong knowledge of risk‑based approaches to qualification and validation in a biotech quality environment.
  • Hands‑on experience with qualification and validation of process equipment, isolators, bioreactors, clean utilities, automation systems, sterile filling, and cleanroom facilities.
  • Solid understanding of relevant regulations and guidelines, including US and EU frameworks (e.g. FDA, EMA), ICH guidance, and industry best practice.
  • Proven track record of working in a fast‑paced team environment, meeting deadlines, and prioritising work across multiple projects.
  • Strong analytical and communication skills, sound judgement, and the ability to work effectively with colleagues and stakeholders.
  • Excellent problem‑solving capability, with experience in root‑cause investigation and CAPA determination.

If this roles is of interest to you, apply today!


Apply now

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Contact us

Mark Chaumeton
Client Services Manager
Mark Chaumeton

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