Snr. Commissioning & Qualification Engineer
The Commissioning & Qualification (C&Q) engineer will be responsible for managing and coordinating all commissioning and qualification activities within the investment projects in order to deliver qualified systems, according to cGMP, and monitoring the quality of these activities.
- Act as subject matter expert in projects for C&Q related issues, under direction of a project manager and/or C&Q manager.
- Responsible for the commissioning and qualification of systems and therefore is in charge (C&Q lead) of the C&Q teams composed of representatives of relevant departments, like local QA, QC's, technical supporting groups and stakeholders.
- Responsible for the C&Q management, including planning, C&Q deliverables and setting out C&Q related strategies.
- Write Validation Project Plans, project close-out Validation Project Reports.
- Write protocols and summary reports and performs qualification activities on the basis of the protocols (or have them being written and / or performed by others).
- Assesses independently whether equipment / systems should be qualified and reviews this with QA.
- Review commissioning (FAT and/or SAT) and qualification documents established by others or by external companies and has these documents to be changed according to his insights.
- Supervise and controls C&Q activities carried out by third parties.
- Reviews turn over packages established by suppliers.
- Monitor developments on relevant C&Q guidelines and communicate them within the C&Q group.
- Fluent in English and Dutch, & Preferably German.
- MSc or experienced BSc degree in (Bio)chemical Engineering, Biochemistry, Applied Science.
- Strong analytical skills, ability to understand automated process systems. ·
- Excellent communication skills - Team player - Willing to travel & work outside office hours.
- Preferably experience in the food or (bio)pharmaceutical industry, as a technical or C&Q engineer or production supervisor.
- Good writing and planning skills.