Computer System Validation Engineer (CSV)

Proclinical is partnering with a leading pharmaceutical company to advertise a vacancy for a Computer System Validation (CSV) Engineer position. The organisation develops, manufactures, and markets generic and proprietary ophthalmic products. The CSV Engineer will be responsible for all computer system validation activities to ensure compliance with applicable regulations, including FDA Title 21 Code of Federal Regulations (CFR) Part 11 and Annex 11. They will provide support for computer validation activities in all company facilities. This job will be based in the company's office in Switzerland.

Job Responsibilities:

• Performing analysis, system design, implementation, and validation of manufacturing systems as they related to 21 CFR Part 11.
• Developing computer system validation user and functional requirements.
• Developing and writing project execution plans.
• Performing risk assessments and reviewing technical packages.
• Writing, executing, and reviewing computer validation protocols.
• Developing computer system validation test documentation and performing data integrity testing.
• Reviewing data presented in final summary reports and ensuring data meets acceptance criteria.
• Revising SOPs and/or training procedures in accordance with harmonisation and quality efforts.

Skills and Requirements:

• A Bachelor's degree, preferably in Computer Science.
• A thorough understanding of industry standards and best practices for computer system validation, such as GAMP and ASTM E2500.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

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 contact Jay Foster at +44 203 752 0309 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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