CSV Engineer

We are recruiting a CSV Engineer to join a leading Pharmaceutical company on an initial 9 month contract. This globally focused role offers the opportunity to combine hands-on qualification with project ownership, helping ensure facility equipment, utilities, instrumentation and computerised systems remain compliant and in a validated state. As the CSV Engineer, you will work within a wider validation team, coordinating internal stakeholders and external contractors to deliver commissioning, qualification and validation campaigns.

Your work will be focused on CSV and Data Integrity of analytical equipment.

Your duties as the CSV Engineer will be varied however the key duties and responsibilities are as follows:

• 1. As the CSV Engineer, you will develop, revise and maintain validation plans and procedures. You will write and execute qualification protocols, define acceptance criteria and prepare reports, coordinating scheduling, execution and review with internal stakeholders, vendors and contractors.
• 2. As the CSV Engineer, you will manage commissioning, qualification and validation campaigns, computerised equipment qualification and computer system validation projects. You will generate and execute data integrity assessments, carry out requalification and use performance monitoring and assessments to maintain the validated status of analytical equipment.
• 3. As the CSV Engineer, you will assess the impact of change controls and deviations on validated systems. You will support equipment and process non-conformance investigations, troubleshoot equipment and system failures, and ensure documentation meets current good manufacturing practice and good documentation practice requirements.
• 4. As the CSV Engineer, you will contribute to the design, selection, procurement, installation, commissioning and qualification of equipment. You will also support internal audits and regulatory inspections, follow standard operating procedures, quality and safety standards.

To be successful in your application to this exciting opportunity as the CSV Engineer we are looking to identify the following on your profile and past history:

• 1. Relevant degree in a scientific, engineering or similar discipline is required, with a master's degree preferred.
• 2. Extensive professional experience in validation, engineering or operations, including practical experience in data integrity assessments and CSV.
• 3. A working knowledge and practical experience with current good manufacturing practice and good documentation practice requirements.
• 4. You will bring clear technical writing, strong communication and interpersonal skills, attention to detail and a flexible approach, alongside the initiative to work independently and contribute effectively within a team.

Key Words:
Validation Engineer / Biotechnology / Equipment Qualification / Commissioning Qualification and Validation / Computer System Validation / Data Integrity Assessments / Good Manufacturing Practice / Utilities Validation / Change Control / Requalification / CSV / DI / Data Integrity

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.