Validation Engineer II (GMF105)
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Validation Engineer II (GMF105)Apply Now
- Prepare and implement the validation documentation required to assure the proper development of a project and support regulatory submissions.
- Act as a validation representative for projects, with support of the Site Validation Lead or Validation Supervisor.
- Define and implement all validation activities related to the project.
- Develop the Validation Plans: define validation methodology and approach. submit to the Site Validation Lead or Validation Supervisor for review.
- Provide validation expertise for the development of the project.
- Lead the risk assessment related to the project.
- Support and review URS, FS and DS definition
- Prepare and implement FAT, IQ, OQ & PQ protocols.
- Assure requirements traceability throughout the whole project validation file (from URS to PQ).
- Organize and coordinate FAT, IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required) in such a way that all of them concur with the timeframes committed with the project leader.
- Analyze, interpret, document and report the testing results.
- Ensure the follow-up and tracking of the validation activities.
- Update the validation documentation system.
- Assure feedback of status and issues to Site Validation lead or Validation Supervisor.
- Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.
- Manage deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-up upon.
- Take part in internal/external audits.
- Provide the required information to support the preparation of facility & process related files for the various regulatory agencies.
- Support the coordination of junior validation engineers and contractors.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0037296