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.
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