We are hiring a CWQA - Computer System Validation Engineer for the Brussels area.
We are looking for Intermediate to Senior Engineer who will bring their expertise with them and drive our projects to completion.
The successful candidate has experience with automation systems: PLC, HMI, SCADA, DeltaV, Archestra.
As a CWQA Engineer your primary task and responsibilities are:
- Writing, reviewing and approving of validation plans and validation summary reports.
- Reviewing and approving of Technical Change Description.
- Reviewing and approving of IQOQ protocols & reports, PQ protocols & reports, ...
- Reviewing of CVS specific SOP's and Templates.
- Ensure the proper execution of the qualification and validation activities with respect of the client validation methodology.
- Univeristy (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
- Certification in computer system validation or equivalent is a plus.
- Experience in a computer systems validation role.
- Knowledge of SAP, MS-Office
- Knowledge of automation systems (PLC, SCADA, HMI, DeltaV, Archestra) is an asset.
- Hard Skills:
- CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, ...)
- Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, ...)
- Soft Skills:
- Critical mind
- Team player
- Good communication skills
- Good analytical skills; ability to investigate and ask questions, on the shopfloor.
- Autnomous, Rigorous, Structured, Systematic.
- Ability to work in team, multidisciplinary environment; lead and inpact cross-functional team members.
- Quality Oriented
- Good knowledge of French and English
- Flexibility to work on weekends and night times depending on production schedule
All applications will be treated in strictest confidence.
Attractive rates, while working in a multi-disciplinary environment, in a vibrant expanding international company.