Job Description
We are seeking a skilled Validation Engineer to join our team in supporting a new project. The successful candidate will play a key role in ensuring the ongoing validation and compliance of new equipment, systems, and processes.
The ideal candidate will have experience working in a healthcare manufacturing environment, ideally within the pharmaceutical sector. They will be capable of troubleshooting validation issues associated with projects, process development, etc., and have a full understanding of relevant quality and compliance regulations.
Responsibilities
* Execute FAT/SAT/IOQ protocols including generation of protocols and reports.
* Design, execute, and report on validation studies for equipment, systems, and processes.
* Ensure validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental, etc).
* Provide technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and dehydrogenation.
* Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
* Maintain validation documentation through the validation lifecycle.
* Participate in external regulatory inspections.
* Support Site Change Control process.
Required Skills and Qualifications
* Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering Chemical/Mech/Elec)
* Experience: 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
* 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 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.
* Ability to use MS Project and SPC packages an advantage.
* Understands KPI's for the site.