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, 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.
* 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.