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Validation Engineer

  • Job reference: 926672
  • Location: Leeds, West Yorkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 18/07/2019

Orion Group are looking for a Validation Engineer for our multinational medical devices client based in the West Yorkshire area on an initial 6-month contract with the potential to extend.

Job Purpose
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

Main Responsibilities of the role

  • 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

Desired Experience and Background of the successful candidate

  • Knowledge of bespoke validation. Process knowledge and documentation
  • 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
  • Must be able to lead and give direction to Validation Projects and Teams
  • The individual must also be an active team member in Validation activities

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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