CSV Engineer

Ref. 1396

CSV Engineer

Our client is a leading global pharmaceutical company, and they are seeking a CSV SME to join their team at their site in county Galway on a 6-month contract role.

This role is responsible for executing and reviewing the activities in compliance to the company’s CSV program and the designated person shall have the self-driven approach in the capacity of computer system validations & associated areas. The successful candidate needs to be adept at protocol generation and execution as well as risk assessment and report writing.

Essential Duties and Responsibilities:

• Preparation, execution and reporting of GxP computerized systems validation deliverables at site.
• Ensure all validation activities adhere to regulatory requirements and company standards.
• Ensure compliance of all GxP computerized systems validation activities at the site.
• Maintain the validated state of all GxP computerized systems used at the site.
• Ensure self-inspection and remediation activities related to GxP computerized systems.
• Conduct periodic reviews of all GxP computerized systems at the site to ensure continued compliance.
• Oversee end-to-end implementation of assigned projects, including tracking progress, following up on tasks, and managing escalations.
• Provide inputs for the revision and implementation of Computerized System Validation (CSV) procedures.
• Manage associated QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs.
• Provide training to cross-functional team (CFT) members on CSV-related procedures.
• Maintain an updated inventory of GxP computerized systems.
• Review protocols, QMS documents, CSV deliverables, and other related documents to ensure accuracy and compliance.
• Ensure the site is prepared for all audits and actively participate during audit processes.
• Perform other duties as assigned.

Requirements:

• Bachelor’s degree (or equivalent) in computer science, Information Technology, Engineering or a related field with 4 – 6 years of experience. A combination of experience and/or education will be taken into consideration.
• Must possess strong knowledge of regulatory requirements and industry standards for GxP computerized systems
• Must possess demonstrated ability to drive compliance through delivery of CSV activities.
• Ability to operate independently and provides direction to other team members as required.