CSV Engineer

Our client, a leading Biotech focusing on the discovery and development of novel biologics, are seeking to hire a CSV Engineer.

Job Responsibilities:

• Establish key deliverables of computer and automated validation, User requirement specification (URS), Functional Requirement Specification (FRS), Validation Plans, impact risk assessment system
• Collaborate to complete internal audits, plan, implement and report changes or upgrades to computer systems
• Generate and update supporting documentation such as system specifications in accordance to the required standards
• Focus on problem identification and help in processing of CAPA reports and change controls in manufacturing process
• Generate validation summary reports to summarize and document all validation activities
• Troubleshoot system problems, identify the need for new systems and make modifications to the existing system to optimize throughput and reduce process cycle time
• Monitor incident and their remediation plan for closing the incident
• Ensure IT Compliance to Regulatory Audits which includes Swiss medic & ITGC audits
• Ensure the integrity of all data generated by validated computer systems.

Skills and Requirements:

• Bachelor/MSc or equivalent in a recognised university in a technical discipline
• Experience in a pharmaceutical industry or related GMP environment,or equivalent.
• Knowledge of regulatory guidelines and Global cGMP compliance requirements
• Knowledge of Global Computer System Validation
• Strong sense of discipline, organisation skills and hands-on approach to work
• Excellent communication, interpersonal and listening skills with the ability to influence individuals and teams

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 207 4400 671 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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