
A New Path in Validation Engineering
4 days ago
Job Title: Validation Expert
We are seeking a skilled Validation Engineer to join our organization in Waterford. The successful candidate will play a key role in ensuring the on-going validation and compliance of existing and new equipment, systems, and processes.
About the Role
- Develop, execute, and report on PV/Process Performance Qualifications.
- Design, execute, and report on validation studies for equipment, systems, and processes.
- Maintain up-to-date knowledge of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and dehydrogenation.
- Support Site Change Control process.
Key Responsibilities
- Plan, design, and execute validation projects according to industry standards.
- Ensure validation studies meet all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.).
- Collaborate with cross-functional teams to achieve project goals.
- Analyse data and provide recommendations for improvement.
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.
- Able to execute projects to plan.
- Good knowledge of quality management systems.
- Ability to use MS Project and SPC packages an advantage.
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