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Our client, a leading company in the pharmaceutical industry, is seeking a Senior CSV Commissioning and Qualification (C&Q) Engineer to join their team in Belgium. As the Senior CSV C&Q Engineer, you will lead the CSV C&Q portion of the project, ensuring all activities are completed safely, on schedule, and in compliance with system requirements, specifications, and project guidelines.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior CSV Commissioning and Qualification Engineer will be varied; however, the key duties and responsibilities are as follows:
1. Act as the CSV C&Q Subject Matter Expert and Compliance Lead, providing guidance to suppliers and the project team in all CSV C&Q activities from design to field execution and summary report approval.
2. Lead the CSV C&Q strategy based on the CSV Validation Master Plan, including aspects such as 21-CFR-Part 11 compliance, audit trails, electronic records, system security, and data management.
3. Liaise with IT and automation SMEs to ensure correct implementation and testing of both network and equipment PLC levels, including process automation aspects for EMS, BMS, and integrated systems.
4. Draft or provide technical guidance on document drafting, coordinate reviews and approvals of CSV C&Q documents, and drive 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. Extensive industry experience in delivering CSV Commissioning and Qualification for pharmaceutical or biotechnology projects.
3. A working knowledge and practical experience with risk-based approaches to CSV commissioning and qualification, including ISPE best practices, GAMP-5, and GMP regulations.
Key Words:
CSV Commissioning / Qualification Engineer / Pharmaceutical / Biotechnology / GMP compliance / 21-CFR-Part 11 / Process Automation / Risk-based approach / ISPE best practices / GAMP-5 / Validation Master Plan
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.
Our client, a leading company in the pharmaceutical industry, is seeking a Senior CSV Commissioning and Qualification (C&Q) Engineer to join their team in Belgium. As the Senior CSV C&Q Engineer, you will lead the CSV C&Q portion of the project, ensuring all activities are completed safely, on schedule, and in compliance with system requirements, specifications, and project guidelines.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior CSV Commissioning and Qualification Engineer will be varied; however, the key duties and responsibilities are as follows:
1. Act as the CSV C&Q Subject Matter Expert and Compliance Lead, providing guidance to suppliers and the project team in all CSV C&Q activities from design to field execution and summary report approval.
2. Lead the CSV C&Q strategy based on the CSV Validation Master Plan, including aspects such as 21-CFR-Part 11 compliance, audit trails, electronic records, system security, and data management.
3. Liaise with IT and automation SMEs to ensure correct implementation and testing of both network and equipment PLC levels, including process automation aspects for EMS, BMS, and integrated systems.
4. Draft or provide technical guidance on document drafting, coordinate reviews and approvals of CSV C&Q documents, and drive 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. Extensive industry experience in delivering CSV Commissioning and Qualification for pharmaceutical or biotechnology projects.
3. A working knowledge and practical experience with risk-based approaches to CSV commissioning and qualification, including ISPE best practices, GAMP-5, and GMP regulations.
Key Words:
CSV Commissioning / Qualification Engineer / Pharmaceutical / Biotechnology / GMP compliance / 21-CFR-Part 11 / Process Automation / Risk-based approach / ISPE best practices / GAMP-5 / Validation Master Plan
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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