Validation Engineer

Location
Waterford
Salary
EUR65.00 - EUR66 per hour
Posted
08 Sep 2022
Closes
27 Oct 2022
Ref
BBBH5150
Contact
Zaharia Ahmed
Sector
Engineering
Job Type
Contract
Hours
Full-time

Validation Engineer

Description:
In the Validation Engineer role, you will be required to support capital projects/equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of equipment, systems and processes at Sanofi Ireland.

The following activities will be included as part of your role:

  • Designing, executing and reporting on validation studies for equipment, systems and processes.
  • Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
  • Providing technical interpretation and guidance of current US FDA and EU validation requirements for solid dose manufacture, aseptic processing, lyophilisation, sterilisation and depyrogenation
  • Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times. Computerised Systems compliance would be beneficial.
  • Maintaining validation documentation through the validation lifecycle
  • Participation in external regulatory inspections

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