
Senior Validation Specialist
4 days ago
We are seeking a skilled Validation Engineer to join our team in Waterford, Ireland. This is an exciting opportunity for a professional with expertise in validation and compliance to support new product introductions, equipment qualification, and site requalification programs.
Key Responsibilities:- Design, execute, and report on PV/Process Performance Qualifications.
- Design, execute, and report on validation studies for equipment, systems, and processes.
- Evaluate and ensure that validation studies comply with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.).
- Provide technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and dehydrogenation.
- Maintain the validation status of equipment and systems in accordance with cGMP at all times.
- Promote validation documentation through the validation lifecycle.
- Participate in external regulatory inspections.
- Support Site Change Control process.
- 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 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.
- Ability to use MS Project and SPC packages an advantage.
- Understands KPI's for the site.
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