Senior Process Engineer position where you maintain and develop new and improved production processes under GMP and ISO13485 for a medical devices / pharmaceutical company in the Bussum area.
As Process Engineer you are the senior in a small team of process technologists. You will mainly focus on improving the production process by developing new processes, validation and qualification of the production process, and building production lines. Furthermore you will be maintaining the current production process by solving problems, following up with Corrective Actions and Preventive Actions (CAPA's), following up Out Of Specs (OOS), etc. All this according to GMP and ISO13485 quality guidelines.
- Improvement of the production process;
- Implementing and validating new process lines;
- Solve occurring problems, calibrations, CAPA's, OOS, etc.;
- Working together with equipment validation, QA and production;
- Work according to GMP and ISO 13485.
- Several years of experience as a process technologist or process engineer;
- Experience in medical devices or pharmaceutical industry is a must;
- Knowledge of GMP and/or ISO13485 guidelines;
- BSc+ level working and thinking level;
- Experience with Equipment Validation (IQ, OQ, PQ) and QA is a huge plus;
- Contract: Long term starting with 1 year contract;
- Salary range: €3500 to €4500 per month;
- Benefits: 13th month, good travel reimbursement, partly working from home possible;
- Working Hours: fulltime (32 hours also possible)
- Region: Bussum area
Vacancy number: 20663