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.