Summary
Our client is a bio pharmaceutical company in Waterford seeking a Qualification Engineer who will be required to support the site requalification program.
The Qualification Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes at the facility.
Responsibilities
Coordinate designing, executing and reporting on periodic qualification program.
Designing, executing and reporting on periodic requalification studies for equipment, systems and processes.
Ensuring periodic qualification studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental).
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 in compliance with cGMP at all times.
Participation in external regulatory inspections.
Support Site Change Control process.
Qualifications & Experience
Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering
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.
Ability to use MS Project and SPC packages an advantage
Understands KPIs for the site.
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