Periode: 2 year to permanent
Our client is a consultancy in the food and pharmaceutical industry. They participate in very attractive projects for experienced engineers in the pharmaceutical industry. They offer challenging, varied projects with ample opportunities for personal contributions and development.
Tasks related to this work:
- Execute project activities for procedures, utilities, systems and equipment
- You will have the responsibility to create and follow up the required change notifications
- You will be responsible for defining and executing the engineering tests, verification and validation of assigned equipment. You define the validation approach, create test protocols for engineering tests, create verification and validation documents, executes tests, coordinates SME and system owner approvals. Also responsible to solve and document deviations and actions (CAPA’s, risk assessments, CGMP review, new document versions).
- Review documentation of technical specs (Engineering Design Specification or technical spec, P&ID’s, electrical diagrams
- Strictly apply all GMP related procedures and SOP's.
Your results, problems and (day to day) activities will be in coorperation with your projectleader or manager.
- MSc or BSc in Engineering (Mechanical or Process Engineering or likewise through experience)
- Few years experience in the Life Science/Pharmaceutical industry.
- Spoken and written skills in English. If you master the Dutch language only we will find a way to make it work as well.
-Good documentation skills, able to deliver complete and 'well documented' documents
-Good communication skills
-Pragmatic, pro-active, knows how and when to take the lead
-Focused on results
-Experienced in planning and project coordination (MS Project is a plus)
-Quality minded – experience in pharma (GMP, risk assessments, verification & validation)
-Hands-on problem solving skills