CQV Engineer
- Randstad
- 3500.00 - 5000.00
- 32-40 uren
- HBO
Opdrachtgever
Our client is a nationally operating service provider that advises its customers on, designs, builds and maintains industrial processes.
Opdrachtgever
Our client is a nationally operating service provider that advises its customers on, designs, builds and maintains industrial processes.
The organisation is characterised by an informal, flexible working environment with short lines of communication, where atmosphere and collegiality are of paramount importance. In addition, there is room and guidance for your personal and professional development through education and training.
functie Vereisten
Experience with production equipment:- Wave rockers
- Single Use Bioreactor (SUB)
- Single Use Mixer (SUM)
- Fridges/Freezers
- Lauda
- Filter Integrity Tester (FIT)
- Bio welders
- Medical Sealers
- Sterile Connection Device (SCD)
Being able to write the following documents:
- URS
- Validation Assessment/ Component Impact Assessment
- Risk Assessment (FMEA)
- IO(P)Q Protocol / report
Other pluses:
- Working with FPX
- Familiar with systems: TruVault, Comet, SAP, Meridian
- High Communication skills
- Dutch is a plus, definitely not a must.
Wat krijg je?
- Pension entitlement as from day one
- Collective WGA / WIA insurance
- NBBU / ABU collective labor agreement
- 25 holidays days
- 8,33% holiday allowance
- 100% payment in case of illness after one waiting day
- Travel allowance
Werkzaamheden
We atre looking for a Commissioning and Qualification Validation Engineer, to support with a project.We are looking for someone who is familiar with the engineering process of writing URSs, IOQ protocols and reports and if possible, validation assessments and or Component Impact Assessments. Being familiar with FMEA risk assessment is a big plus, not a requirement.
The person needs to be quality minded, the documentation needs to be of a high standard and adhere to basic GMP, and the engineer should preferably have knowledge of the equipment below (All is included within the project) or is eager to learn quickly with a base of asking questions to gain knowledge quickly.
If possible, this person is very independent in their start-up, however if needed support can be granted from myself on the project to ensure the person is capable of completing the project in the expected timelines and with the correct quality.
