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Process Validation Engineer

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Job Summary

  • Dublin
  • Permanent
  • JN -012024-1954703
  • Jan 25, 2024
  • Competitive
Job Description

I have an exciting opportunity for a process validation engineer for a well-known medical device company based in Dublin.

This role will ensure that the design, installation, and operation of the plant and equipment has been validated in compliance with regulatory requirements.

You will have 2 years' experience working in pharmaceuticals, medical device, or diagnostics in a similar process validation role. A degree in engineering, quality or within manufacturing essential for the role. Experience in understanding medical device regulations. Execution of IQ, process development, OQ and PQ on processes as required.

Responsibilities:

  • Use of Company Validation Toolkits.
  • Author User Requirements Specification and System Requirements Specification, leveraging the inputs from Quality, Operational, Automation and Process Development.
  • Review and sign-off of vendor-provided System Design Specification, Functional Design Specification and Design Reviews as a Validation resource, as part of the assigned project team.
  • Validation resource, across a variety of processes, as part of the overall Value Stream.
  • Liaise as Validation representative on ACR process.
  • Maintain site Validation Master Plan in relation to projects.
  • Continuous Improvement-driven upgrades to existing equipment
  • Quality-Driven in-line vision and inspection systems
  • Cross-Line Product Validations to ensure redundancy.
  • Ancillary Equipment Validation.
  • Maintain CFR Part 11 Assessments.
  • Define validation sampling and inspection plans based on Risk Assessment in relation to pFMEA and product specifications.
  • Ensure all product at risk as a result of validation changes are contained prior to ACR closure through QN product hold process.
  • Draft and execute FAT, SAT, MSA, IQ, PD, OQ and PQ on new/revised processes.
  • Root Cause Analysis and containment of deviating product during Validations.
  • Create and control pFMEA, Control Plans and Risk Management documentation through product life cycle.
  • Link with post-validation activities including closure of Change Control and Microbiological testing.

If this role is of interest, please 'apply now' or contact me on 021 2300 300 to chat further.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Aoife O'Driscoll
Aoife O'Driscoll