Summary:
Our client is a global biopharma 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 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 dehydrogenation.
* Ensuring that the validation status of equipment and systems are compliant 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 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.
* Ability to use MS Project and SPC packages an advantage.
* Understands KPI’s for the site.
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