- The process Development Engineer will lead a cross-functional team during new product introduction (NPI) projects in accordance with a pre-approved project plan, schedule and current project management best practice.
- Ensure that critical manufacturing systems and support structures are in place for major technology transfer and NPI projects and provide technical advice on process engineering requirements as needed. Liaise with technology transfer projects in other sites
- Execute early stage feasibility, technical, process optimisation and process validation studies;
- Liaise with the Technical Services Process Support Team to identify process improvement opportunities for legacy products. Propose and implement sustainable solutions to reduce processing times, improve yield, reduce defects and eliminate waste;
- Identify cost-effective opportunities for the introduction of best-in-class manufacturing technologies. Design and introduce these technologies to manufacturing operations;
- Input into the Technical Services management systems including strategic project planning;
- Review of Change Records and Risk Assessments to assess process impact and validation status as required;
- Liaise with other departments, vendors, external consultants & other sites as required;
- The Process Development Engineer will provide regular progress updates on projects and activities within and beyond Process Development Group as stated in project communication plans and/or as required by the relevant stakeholders;
- Adhere to the compliance matrix of business processes and routine departmental tasks;
- Manage the workload and resource plans of direct and indirect reports while supporting individual learning and development objectives through coaching and mentoring;
- Comply with the relevant industry and Company quality standards and the cGMP rules pertaining to production;
- May be required to assume responsibilities of Process Support Engineer where applicable, from time to time and as directed by the Manager or Director.
- Degree qualified in a Science or Engineering discipline or Masters in a related field is preferable.
- Ideally 4years’ experience as a Process Engineer with Pharmaceutical industry and New product Introduction project experience
- Operational, project based or validation experience of oral solid dosage manufacturing processes an advantage
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