- Our clients is looking for a dedicated Process Engineer to drive the production aspects of introducing a new suite of pharmacautical/biopharmaceutical products.
- These products will be liquid formulations filled into single-use bags in a Class D environment.
- The role involves working closely on the ground with production personnel and supporting departments to design 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 our clients standard operating procedures and policies.
Core Duties and Responsibilities:
- 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 validation/verification protocols/reports in eDoc.
- Operations Department review of new Master Batch Records/Cleaning records.
- Prepare/request/set-up new labels.
- Design 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 design meetings.
- Attending Process and System Training.
- Assisting with development of BOMs.
- Performs any other duties as outlined by the Supervisor or Departmental head.
Minimum Qualifications and Experience:
- Bachelor’s Degree in Engineering or Science preferably Chemical or Mechanical.
- 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.
- Competence in writing and reviewing cGMP documentation.
- Previous hands-on project management experience in the Pharma/Biopharma sector would be a distinct advantage.
- The role involves working closely with other departments so must be able to work in a team.
- Computer literate.
- 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.
- 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.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
Please note, we do not require agency assistance with this role.