Periode: 1 year
Our client is a consulting company in Food & Pharma. They participate in very attractive projects for experienced engineers within the pharmaceutical industry. They offer challenging, varied projects with ample opportunities for personal contribution and development. For a new project that is going to start in January 2019, we are looking for two Validation Engineers to strenghten their team. Interesting detail: internationals are allowed.
The Validation Engineers will work during regular working hours from Monday to Friday, 8 hours a day, 5 days a week in total 40 hours a week. The following key project steps have been defined:
- Protocol generation and report generation of routine requalification of temperature controlled units (e.g. freezers, fridges, incubators. Note: physical temperature mapping execution is not part of the scope;
- requalification of the HVAC system, CIP system, Small parts washer and Autoclave. This includes protocol generation, equipment performance review and report generation. Note: physical execution of the testing is not part of the scope;
- Equipment, cleaning, system and CSV performance reviews. This includes the paper- and physical inspection needed for the review, as well as the report generation;
- When the Validation Engineers end the project they will transfer all their knowledge and documentation to an employee. This will be initiated by the engineers at least 4 weeks before the contract ends.
The following responsibilities are defined:
- Responsible for achieving compliance with client requirements;
- “hands dirty” approach: executes all work required to achieve and maintain the validated state for manufacturing;
- ensures optimal alignment/interconnection with the Validation Department and QA Department.
- A minimum of five years of experience in a similar position in Pharmaceutical or Biotechnological related industry;
- a Bachelor Degree in: Microbiological, Biochemical, Quality Engineering or Engineering Sciences or Chemistry;
- all-round experience of Validation of computer system, lab equipment and manufacturing equipment;
- capable of work under pressure and in a dynamic environment;
- this position requires excellent reading, writing and speaking English. The ability to speak Dutch is a big plus;
- you have to be able to utilize Microsoft Office Professional Software package including MS Word, MS Excel, MS PowerPoint, and MS Project Management.