Role Summary:
An exciting new opportunity has arisen for a Qualification Engineer to join our client's busy biopharmaceutical facility in Co.
Waterford.
In this role, you will be required to support the site requalification program.
The Periodic Qualification Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes on site.
Core Duties and Responsibilities:
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 company standards and legal requirements (Health & Safety, c GMP, 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 c GMP at all times.
Participation in external regulatory inspections.
Minimum Qualifications and 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.
Natural influencer and works well as part of a multifunctional team.
Highly motivated and self-resilient.
Adaptable and flexible as well as a pragmatically minded problem solver.
Sees projects/tasks through to completion.
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