Validation Engineer

Summary:                      

Our client is a biopharmaceutical company based in Waterford looking for a Validation Engineer to join its team to support a new project ensuring the on-going validation and compliance of new equipment, systems and processes role.

Responsibilities:

• 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 follow cGMP at all times.
• Maintaining validation documentation through the validation lifecycle.
• Participation in external regulatory inspections.
• Support Site Change Control process.

Qualifications & Experience:

• 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.
• Good knowledge of quality management systems.
• Ability to use MS Project and SPC packages an advantage
• Previous Equipment knowledge for example pack lines, Autoclaves, Isolator Technology and fill lines would be an advantage.