Website TPM05426
Summary:
Our client is a global biopharmaceutical company based in Waterford looking for a Validation Engineer who will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes.
Responsibilities:
- Designing, executing and reporting on PQ 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.
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 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.
To apply for this job please visit Orla.Dalytandempm.ie.