Pharmaceutical & Biotechnology

Validation Engineer

  • Contract
  • Cork, County Cork, Ireland
  • 41996617

PE Global is currently recruiting for a Technical Operations Engineer for a leading multi-national BioPharma client based in Cork.

This is an initial 12 month contract position.

 

The Technical Operations Engineer is a member of the Technical Operations (TO) Team with the dedicated focus on

  1. New Product Introduction (NPI) / Life Cycle Management (LCM)
  2. Validation
  3. Process improvements
  4. Standards and new technology deployment

 

The Technical Operations Engineer is expected to continuously focus on safety, quality, GMP and operational discipline. The Technical Operations Engineer / Scientist will report solid line to the Site TO Lead or Site TO Mgr/Director – depending on the site TO structure on the site. The Technical Operations Engineer is responsible for the management and/or execution of the Validation Master Plan(s), including but not limited to process validation, cleaning validation and sterilization validation.

 

The Technical Operations Engineer is a key contributor to NPI / LCM and process improvement initiatives on the site. The level of contribution in the area of validation, NPI/LCM and process improvement initiatives is dependent on the education and/or experience level of the engineer.

Duties of the role/Responsibilities

  • Contribute to LCM / New Product Introduction for the Site
  • Manage / execute the validation program related to LCM / NPI such as process validation, cleaning validation, sterilization validation, aseptic process validation, packaging validation etc
  • Issue / review validation plan, protocols and reports
  • Execute the validation runs in the field and / or oversee the execution done by validation technicians / contractors
  • Be the site TO representative in LCM/NPI project teams as process / validation SME
  • Overall coordination of LCM projects on site, under responsibility of global TO organization
  • Change control Management Technology & product technical life cycle management
  • Manage / execute the annual site Validation Master Plan(s) in the area of process validation, cleaning validation, sterilization validation, aseptic process validation, packaging validation etc
  • Issue / review validation plans, protocols and reports
  • Execute the validation runs in the field and / or oversee the execution done by validation technicians / contractors
  • Review / approve annual product reviews (APR)
  • Own / lead or participate in the CPV (continued process verification) program by issuing plans, protocols and reports and oversee the execution.
  • Lead complex investigations on the site by providing technical expertise (process, cleaning, aseptic, …
  • Provides process / technology input to SOPs, Master Batch Records and change controls
  • Partner with Engineering & Maintenance and contribute to equipment changes / introduction projects on the site

 

Education/Experience

  • Degree in Science or Engineering is required.
  • 5 years Industry relevant experience

 

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on +353 21 4297900 or alternatively send an up to date CV to chloe.slingsby@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

 

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