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CSV C&Q Engineer

  1. Belgium, Brussels
Brussels
  1. Contract
Competitive
  1. Life Sciences
37815
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CSV C&Q Engineer - Belgium, Brussels - 6-9 Month Contract 

We are looking for an experienced CSV C&Q Engineer for a fantastic 5 month contract (with possible extension) 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 and include:
21-CFR-Part 11 aspects:
  • Audit trail,
  • Electronic records, Electronic signatures,
  • System security
  • Access management,
  • Data import/ export
  • Backup/ DRP.
  • Report
  • Liaise with IT SME/ compliance for the correct implementation and testing both at network level and equipment PLC level as applicable.
Process Automation aspects for EMS (Galaxy) / BMS (HVAC/Black Utilities) and integrated system:
  • Graphics/ user interface
  • IO loop test
  • Alarms/ errors
  • Interlocks
  • e-stop/ communication or power lost/
  • Trending (Measurement / Parameter Historization)
  • Interface test
  • Regulation and control loop
  • Automation design documentation/ configuration verification/ HDS testing
  • FDS Sequence testing of CM/ EM/ Phase (Process management)/ Parameters / Recipe creation and management/ Batch/ cycle/ analysis report.
  • Liaise with automation SME for the correct implementation and testing of automation aspects both at platform level and equipment PLC level as applicable.
Requirements:
  • Requires extensive 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 with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ Eudralex Annex 1, ASTM E2500/ electronic execution.
  • 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.
  • Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
If this role is of interest to you, please apply now!

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