About the job
Our Team:
In the Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes. The following activities will be included as part of your role.
Main responsibilities:
The following activities will be included as part of your role:
* 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
Experience: 3-5 years' experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
Soft skills:
* Natural influencer and works well as part of a multifunctional team.
* Highly motivated and self-resilient.
* Adaptable and flexible as well as a pragmatically minded problem solver.
* Sees projects/tasks through to completion.
Technical skills:
* Capable of troubleshooting validation issues associated with projects, process development etc.
* Competent technical knowledge of pharmaceutical plants.
* Previous validation/product development experience would be highly advantageous for the role.
* Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
* Knowledge of requirements for of GAMP, ISPE Baseline guides.
* Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
* Full understanding of relevant quality and compliance regulations
* Able to execute projects to plan.
* Good knowledge of quality management systems.
* Good communication skills at organisation, team and individual levels.
* Ability to use MS Project and SPC packages an advantage
* Understands KPI's for the site.
Education: Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)
Languages: English