CSV C&Q Engineer
- Belgium, Brussels
- Contract
- Compliance / Quality Assurance
We are looking for an experienced CSV C&Q Engineer for a fantastic 6-12 month contract based in Brussels.
You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.
This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.
Responsibilities:
- Ability to provide guidance to supplier and the rest of the team in all CSV C&Q activities for the system(s), from design to field execution and to summary report approval.
- Lead the CSV C&Q strategy based on CSV VMP
- Process Automation aspects for EMS (Galaxy) / BMS (HVAC/Black Utilities) and integrated system:
- PCS (DCS) SCADA (stick-built WFI distribution, clean gas distribution….)
- PCS PLC equipment (WFI gen/ decontamination station/ lab water/ auto/pw/filling line….)
- Draft or provide technical guidance on document drafting by partner/ supplier
- Drive correct CSV verification testing, compliance and acceptance.
- Generate and or review change controls related to CSV C&Q and drive closure in a timely manner
- Ensures all personnel who perform C&Q activities for the system(s) have relevant training assigned
- Extensive experience of Lead/SME experience in International CAPEX Commissioning and Qualification.
- Technical qualification at third level or equivalent in Engineering.
- Extensive knowledge and demonstrated experience delivering CSV Commissioning and Qualification for Pharmaceutical / Biotechnology projects.
- Strong understanding of a risk-based approach to CSV commissioning and qualification within the biotechnology industry.
- Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry is preferred.
- Knowledge of safety, GMP and environmental regulatory requirements.
- Ability to make decision under pressure and demonstrated strong Communication/ Leadership skills.
#LI-CB1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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