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.