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Please note this is a 12 month Full-Time Contract position.
Duties and responsibilities
Process Engineer is 100%-dedicated to drive the production aspects of introducing a new suite of pharmaceutical/biopharmaceutical products at Arklow (Project TOLSO), to launch Q1 2020. These products will be liquid formulations filled into single-use bags in a Class D environment, and the role involves working closely on the ground with production personnel and supporting departments to the process, prepare and execute test protocols, organise the production process equipment layout, co-ordinate samples and materials through warehouse/production, and liaise with the program manager and other departments. The project will require a full-time engineer for 12 months and is a tremendous opportunity for an ambitious hands-on engineer to become a core team player in a small team working to an ambitious launch date. All work to be carried in compliance with cGMP and company standard operating procedures and policies.
Essential: Level 8 qualification in Engineering or Science discipline.
Desirable: Chemical or Mechanical Engineering.
Previous project management experience with New Product Introductions, preferably working in the Bulk Pharmaceutical or Biopharmaceutical industry.
Previous experience with aseptic filling would be advantageous.
Some competence in the use of Inventory Management systems (eg SAP©, barcode systems) with proven numerical and literacy skills.
Job Specific Competencies
The successful candidate will have proven project management experience and will be self-motivated to drive the project to a successful on-time launch date. The role involves working closely with other departments. Typical activities will include:
- Attending weekly meetings to review items on NPI schedule
- New code request forms – preparation and review
- Review/approve New Process Introduction documentation
- eDoc review of method / protocols/reports in eDoc
- eDoc review of process / protocols/reports eDoc
- Operations Department review of new Master Batch Records/Cleaning records
- Prepare/request/set-up new labels
- process for sterile filter integrity tests
- Co-ordinate Process Fill and Mixing Process Validations, and Cleaning Validations including co-ordination of protocol samples through Production group
- Involvement in change controls/cGMP and EHS Risk Assessments
- Training production operators on the new process
- Troubleshooting initial batches through the plant and dealing with issues as they arise
- Attending process meetings
- Attending Process and System Training
- Assisting with development of BOMs
- Performs any other duties as outlined by the Supervisor or Departmental head.
- Competence in writing and reviewing cGMP documentation
- Previous hands-on project management experience in the Pharma/Biopharma sector would be a distinct advantage.
- Computer literate.
- A pragmatic approach to problem-solving
- Mature judgment, problem-solving and decision-making ability.
- Ability to identify, develop and deliver on process improvement opportunities.
- Energetic committed individual who is used to working to tight deadlines, and can work in a flexible way when necessary.
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