4992
Process Validation Specialist
Waterford, Ireland
Life Science
Fix Term Contract
4992
Posted on:
May 5, 2025
The Highlights:
- Working with clinical and commercial products
- Great Workculture and Approachable management
- Joining a well - established team
The Role:
Elusav Recruitment have an amazing opportunity for a Process Validation Specialist with a leading global biopharma company in Waterford, Ireland.
As the Process Validation Specialist, you will be required to support new product introductions, equipment qualification and the site requalification program.
Job Responsibilities:
- Designing, executing and reporting on PV/Process Performance Qualifications. 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:
- 3-5 years’ experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
- Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec).
- Capable of troubleshooting validation issues associated with projects, process development etc. 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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Process Validation Specialist
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