You will play a key role in ensuring the ongoing validation and compliance of equipment, systems and processes at Sanofi Ireland. Key responsibilities include designing, executing and reporting on PV/Process Performance Qualifications, validation studies for equipment, systems and processes, and ensuring that these studies are managed in conjunction with required standards and legal requirements.
Main Responsibilities:
* Designing, executing and reporting on PV/Process Performance Qualifications
* 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 aseptic processing, lyophilisation, sterilisation and depyrogenation
* Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times
* Maintaining validation documentation through the validation lifecycle
* Participation in external regulatory inspections
* Support Site Change Control process
About You:
We are seeking a highly skilled and experienced Validation Engineer with 3-5 years' experience working in a Healthcare manufacturing environment - ideally part of which would be in the pharmaceutical sector. The ideal candidate will have strong technical knowledge of pharmaceutical plants, previous validation/product development experience, and knowledge of Process Validation regulations, current process validation and technical transfer industry practices.
The successful candidate will possess excellent communication skills, able to execute projects to plan, and have a good understanding of relevant quality and compliance regulations. A degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec is essential.