In partnership with an industry-leading bio-pharmaceutical CDMO in Geleen, we are looking for a Commissioning Qualification Validation engineer to carry out a variety of tasks related to the validation of equipment and facilities. The scope of activities includes the coordination on the installation of equipment, drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements.
RESPONSIBILITIES
- Prepare validation documents including URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
- Execution of IQ/OQ and PQ for equipment, systems and utilities.
- Write reports of completed CQV activities
- Stay informed of industry regulatory changes as it applies to equipment / facility validation.
- Support in writing and/or revising procedures applicable to the Engineering activities.
- Support the Engineering group to prepare the validation, requalification and maintenance program.
PROFILE
- Experience in CQV role or equivalent: 3-6 years
- Background: Pharmaceutical industry, Medical Device industry - Engineering, Biotech, Quality Engineering or QA
- Education: Bachelor level or equivalent, preferably in (Bio)Medical Engineering, Biotechnology or similar
- Certifications not required, but demonstrable knowledge in GMP environment is preferable, experience with Good Documentation Practices, Data Integrity and ALCOA++ principles is highly preferably
PRACTICALITIES
- Start: ASAP
- Contract: 1 year, possibility of extension
- Language: English a must, Dutch a plus
- 40 hours per week, 80% on-site
- Location: Geleen
INTERESTED?
Interviews can happen this week!
If you’re interested in the above description, please apply with your CV today. For further information, please contact Vlad at +31 (0)20 20 44 502 or by email at v.niesov@panda-int.com