Validation Engineer

Contract
Leinster
Posted 1 year ago

As part of a significant expansion of the site, an exciting opportunity has come to join the Commercialisation team to transition from a project phase to a fully operational facility delivering life-saving products to patients.

 

Responsibilities

 

  • Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests.
  • Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
  • Act as validation SME on the equipment within the area assigned. Leveraging testing from Commissioning and Qualification.
  • Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
  • Implementing the requirements as outlined in the site / project Validation Master Plan.
  • Coordination of engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.
  • Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
  • Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Owning Change Management process for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.
  • Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).
  • Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
  • Keep up to date with scientific and technical developments, best practices and attend seminars as required.
  • Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.

 

 

To apply contact Martin Lynch on 087-344 3581.

 

Email CVs to mlynch@mile.ie

Job Features

Job CategoryValidation Engineer

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