Jobs

Validation Engineer - Yorkshire

Medical/Pharmaceutical - Quality
Ref: 319 Date Posted: Monday 05 Aug 2019
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Job Description-

 

Key Result Areas

  • Continuous Improvement Focus
  • Conduct validation activities in compliance with US and EU relations, GBSC procedures and EHS requirements
  • Participate in the design of systems and equipment to ensure that they comply with GMP requirements
  • Develop validation documentation as required (e.g. specifications, plans, protocols, procedures)
  • Develop pFMEA documentation to support processes as part of Validation process
  • Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls)
  • Execute qualification protocols as required
  • Compile relevant documentation from contractors, suppliers and other departments for inclusion in reports
  • Generation/Modification of Process Specifications as required
  • Prepare and execute validation protocols/reports
  • Initiate and implement change control activities in accordance with site procedures
  • Develop validation plans for site and projects as part of validation planning or re-validation activities as appropriate
  • Track and resolve exceptions during qualification activities
  • Coordinate qualification activities with engineering, construction and commissioning activities
  • Coordinate qualification activities with contractors and vendors as required
  • Coordinate qualification document review and approval
  • Collate and organise qualification files for turnover to QA DC/ route of PLM
  • Attend identified training
  • Participate in cross-functional teams as required

 

 

Skills / Knowledge:

Essential:

Knowledge of bespoke validation.

Process knowledge and documentation.

 

Desirable:

  • In depth knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
  • High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
  • Working experience of validation computer systems for use in a FDA regulated environment.

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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