We're seeking a skilled Validation Engineer to join a leading global biopharmaceutical company. In this role, you will be responsible for ensuring that systems, equipment, and processes meet regulatory standards and operate reliably throughout their lifecycle. You'll collaborate cross-functionally with Quality, Engineering, and Manufacturing teams to support validation activities in a GMP-compliant environment.
Key Responsibilities:
The following activities will be included as part of your role:
* Executing FAT/SAT/IOQ protocols including generation of protocols and reports.
* 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
Education, Skills & Qualifications:
* Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)
* 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 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.
* Previous Equipment knowledge for example pack lines, Autoclaves, Isolator Technology and fill lines would be an advantage.