Process Validation Engineer
The Highlights:
The Role:
Elusav Recruitment have an excellent opportunity for a Process Validation Engineer to work with a leading Global Biopharma company in Waterford. This is an incredibly successful biopharmaceutical drug product facility and the role has come about due to capacity expansions, as well as the introduction of new equipment, systems and processes to site.
The Process Validation Engineer will support new product introductions, equipment qualification and the site requalification program. Will have a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes on site.
Job Responsibilities:
- Designing, executing and reporting on PV/Process Performance Qualifications.
- Designing, executing and reporting on validation studies for equipment, systems and processes.
- Ensuring validation studies are managed in conjunction with all required 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.
Job Requirements:
- 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.
If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien on stephen@elusav.com or +3536959993.
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