Skills

Communication Leadership Test

Job Specifications

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!

About the Company

We are an award-winning Recruitment Consultancy who have established long-term relationships since 1992, working with talented professionals in more than 30 countries throughout the world & operating in offices within the UK (Berkhamsted), USA, Ireland & The Netherlands. Our team are experts in their sectors, with an award-winning training programme that serves to progress careers as well as ensure candidates & clients always receive the best possible service. Our expertise covers three business areas: Life Sciences, Renew... Know more