Qualification Engineer

ROLE OVERVIEW

A leading company in the biotechnology industry, located in the heart of London, is seeking a Senior CSV Commissioning and Qualification (C&Q) Engineer. This role offers the chance to lead and shape critical projects, ensuring compliance and safety in a dynamic and innovative environment.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Senior CSV Commissioning and Qualification (C&Q) Engineer will be varied however the key duties and responsibilities are as follows:

1. Act as the CSV C&Q Subject Matter Expert, providing guidance to suppliers and the team on all CSV C&Q activities from design to execution and report approval.

2. Lead the CSV C&Q strategy, ensuring compliance with 21-CFR-Part 11 aspects, process automation, and system security.

3. Draft or provide technical guidance on document drafting, coordinating review and approval of CSV C&Q documents.

4. Drive correct CSV verification testing, troubleshoot issues, and ensure timely closure of change controls related to CSV C&Q.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Senior CSV Commissioning and Qualification (C&Q) 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/Biotechnology projects.

3. A working knowledge and practical experience with risk-based approaches to CSV commissioning and qualification within the biotechnology industry.

Key Words:

CSV / Commissioning / Qualification / Biotechnology / Pharmaceutical / Compliance / 21-CFR-Part 11 / Process Automation / GMP / Risk-based Approach / Engineering

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.