An exciting opportunity for experienced Process Engineers to join a leading Pharmaceutical company located in Waterford, with permanent and contract roles available.
- Identify and manage process improvements and projects.
- Lead in the procurement, introduction, commissioning and qualification of process equipment and subsequent process validations.
- Ensure qualification methodology is clear and integrated into the project from URS onwards.
- Ensure documentation, training and handover meet the internal customers’ expectations.
- Consider life cycle cost in designs for maximum long term efficiency and reliability.
- Plan and execute process validation schedules for manufacturing and packaging processes.
- Write and execute documents for the validation of new and existing processes.
- Liaise with contractors/customers when external resources are required to complete validations.
- Liaise with relevant departments to organise resources/materials/ equipment/facilities/etc and ensure validation activities are planned and executed in line with applicable deadlines.
- Assist with submission/audit/deficiency responses activities when required, in a timely manner.
- Draft/revise/review validation related documents e.g. SOPs, protocols, reports etc.
- Intermediate/senior profile – self-starting, will be leading/co-ordinating process equipment introductions & qualifications, subsequent process validations, organising operations & maintenance support, raw materials for engineering/process optimisation batches, etc.
- Pharma engineering experience highly desired – manufacturing and/or packaging – 3-6 years or more as a guide.
- Candidate will need to be able to be on-site with relatively short notice, in general looking at approx 50% required physically on site time, with ample opportunity to work from home when not required physically on site.
For a confidential discussion and more information on the role, please contact Barry O'Brien.