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Senior Validation Engineer



Location:
Cork
Salary:
Negotiable
Sector:
Quality & Regulatory, Pharmaceuticals, Biopharmaceuticals / Biologics

Summary

This position requires significant expertise in the support of Validation and commissioning in supporting various site projects and documentation review. The successful candidate will be required to support facility/utility/equipment qualifications.

Responsibilities:

  • Responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision, preparing protocols independently, analyzing test results, and preparing technical reports.
  • Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
  • Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget.
  • Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work.
  • Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
  • Previous experience with Change Management, Validation and Commissioning Documentation requirements is strongly desirable.
  • Works directly with operating entities to ensure that deviation investigations, inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • May assist with compliance audits as required.

Education and Experience:

  • 4+ years of relevant experience in a GMP environment related field and a BS.

Berkley Engineering is a specialist recruitment consultancy which recruits pharmaceutical, medical device and clinical professionals throughout Ireland, Europe, Asia and Australia.

For more information and to see all the Engineering Jobs available go to http://www.berkley-group.com

To apply: If you would like to discuss this vacancy further or to discuss your career and other job options in confidence, please telephone Heather Haitse on +353 (0)21 4289616 or send your CV to hhaitse@berkley-group.com

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At Berkley Group, we approach resourcing and recruitment in a way that’s distinctly insightful and personal. We have outstanding knowledge in our four specialist areas: IT, Pharmaceutical & Life Sciences, Engineering and Search & Selection. But as you’ll discover, it’s how we apply this knowledge that makes us different.

Our expertise spans the globe, so we can reach further for the right solutions. And we’re able to deal with a broad range of challenges because we're part of Rethink Group: one of the world's fastest growing providers of talent management, business solutions and recruitment.

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