CSV Engineer

Morgan McKinley; Galway; On-site; EUR 60,000 - 90,000; Full time

Job summary

Morgan McKinley is seeking a CSV Engineer to execute and review activities in line with the company CSV program for GxP computerized systems at the site.

You will drive compliance through validation deliverables, maintain validated state, support audits and QMS processes including CAPAs, change controls, deviations.

The role requires a Bachelor’s degree in computer science/IT/engineering and 4–6 years of experience with regulatory requirements.

Qualifications

• Bachelor's degree in Computer Science, Information Technology, Engineering or a related field.
• Strong knowledge of regulatory requirements and industry standards for GxP computerized systems.
• Demonstrated ability to drive compliance through delivery of CSV activities.

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.
• Oversee end-to-end implementation of assigned projects, including tracking progress, following up on tasks, and managing escalations.
• Provide training to cross-functional team (CFT) members on CSV-related procedures.

Skills

CSV validation

GxP compliance

Regulatory knowledge

Project coordination

Audit readiness

Education

Bachelor's degree in Computer Science/IT/Engineering

Tools

QMS software

Job description

We are looking for a CSV Engineer to execute and review the activities in compliance with the company CSV program; the designated person shall have the self-driven approach in the capacity of computer system validations & associated areas.

Key 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.
• Oversee end-to-end implementation of assigned projects, including tracking progress, following up on tasks, and managing escalations.
• 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.
• 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.
• 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.
• Provide training to cross-functional team (CFT) members on CSV-related procedures.

Skills, Attributes & Experience:

• Bachelor's degree in Computer Science, Information Technology, Engineering or a related field with 4 -6 years of experience.
• Strong knowledge of regulatory requirements and industry standards for GxP computerized systems.
• Demonstrated ability to drive compliance through delivery of CSV activities.