Back to Job SearchWe are actively recruiting a Senior CSV Engineer to join their team in the Walloon Region, Belgium. As the Senior CSV Engineer, you will play a pivotal role in ensuring that all C&Q activities are completed safely, on schedule, and in compliance with system requirements, specifications, and project procedures/guidelines. This role involves providing expertise and leadership across GMP equipment and automation.
This is a mission initially until the end of the year, with likely extension. The available rate is between 55 - 70 euros per hour, 40 hours per week.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior CSV Engineer will be varied; however, the key duties and responsibilities are as follows:
1. As the Senior CSV Engineer, you will act as the CSV C&Q Subject Matter Expert and Compliance lead, providing guidance to suppliers and the team on all CSV C&Q activities from design to field execution and summary report approval.
2. As the Senior CSV Engineer, you will lead the CSV C&Q strategy based on CSV VMP, including aspects such as 21-CFR-Part 11, audit trails, electronic records, system security, and more.
3. As the Senior CSV Engineer, you will liaise with IT and automation SMEs to ensure correct implementation and testing at both network and equipment PLC levels, covering EMS, BMS, PCS, and SCADA systems.
4. As the Senior CSV Engineer, you will draft or guide the drafting of applicable CSV C&Q documents, coordinate reviews, and drive the correct CSV verification testing, compliance, and acceptance.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Senior CSV Commissioning and Qualification Engineer, we are looking to identify the following on your profile and past history:
1. Relevant degree in Engineering or a related field.
2. Industry experience working as a CSV Engineer within a pharmaceutical or biotechnology facility.
3. A working knowledge and practical experience with risk-based approaches to CSV commissioning and qualification, including ISPE best practices, GAMP-5, and relevant GMP regulations.
Key Words: CSV / Commissioning / Qualification / C&Q / Pharmaceutical / Biotechnology / GMP / Compliance / Automation / Engineering / Risk-based approach / ISPE / GAMP-5 / Annex 15 / Eudralex / ASTM E2500
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
This is a mission initially until the end of the year, with likely extension. The available rate is between 55 - 70 euros per hour, 40 hours per week.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior CSV Engineer will be varied; however, the key duties and responsibilities are as follows:
1. As the Senior CSV Engineer, you will act as the CSV C&Q Subject Matter Expert and Compliance lead, providing guidance to suppliers and the team on all CSV C&Q activities from design to field execution and summary report approval.
2. As the Senior CSV Engineer, you will lead the CSV C&Q strategy based on CSV VMP, including aspects such as 21-CFR-Part 11, audit trails, electronic records, system security, and more.
3. As the Senior CSV Engineer, you will liaise with IT and automation SMEs to ensure correct implementation and testing at both network and equipment PLC levels, covering EMS, BMS, PCS, and SCADA systems.
4. As the Senior CSV Engineer, you will draft or guide the drafting of applicable CSV C&Q documents, coordinate reviews, and drive the correct CSV verification testing, compliance, and acceptance.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Senior CSV Commissioning and Qualification Engineer, we are looking to identify the following on your profile and past history:
1. Relevant degree in Engineering or a related field.
2. Industry experience working as a CSV Engineer within a pharmaceutical or biotechnology facility.
3. A working knowledge and practical experience with risk-based approaches to CSV commissioning and qualification, including ISPE best practices, GAMP-5, and relevant GMP regulations.
Key Words: CSV / Commissioning / Qualification / C&Q / Pharmaceutical / Biotechnology / GMP / Compliance / Automation / Engineering / Risk-based approach / ISPE / GAMP-5 / Annex 15 / Eudralex / ASTM E2500
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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