CSV Program Lead — GxP Systems Validation

Biopharma Careers; Inverin; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Excellent career progression opportuni

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a GxP Computerized Systems Validation (CSV) specialist to join our Ireland site. You will prepare, execute and report CSV deliverables, ensuring regulatory compliance and maintaining the validated state of GxP systems.

Responsibilities include coordinating end-to-end project activities, supporting audits, and contributing to QMS actions while training cross-functional teams on CSV procedures.

Qualifications

• Knowledge of regulatory requirements and industry standards for GxP computerized systems.
• Bachelor's degree or equivalent in computer science/IT/engineering or related field.
• Ability to drive compliance through delivery of CSV activities.

Responsibilities

• Prepare, execute and report GxP CSV deliverables at site.
• Ensure all validation activities adhere to regulatory requirements and company standards.
• Maintain the validated state of all GxP computerized systems used at the site.
• Oversee end-to-end implementation of assigned projects, including tracking progress and managing escalations.
• Provide training to cross-functional team members on CSV-related procedures.
• Maintain an updated inventory of GxP computerized systems.

Skills

GxP regulatory knowledge

CSV delivery & reporting

Audits & compliance

Education

Bachelor's degree in computer science/IT/engineering or related field

Job description

Viatris is seeking a GxP Computerized Systems Validation (CSV) specialist to join our Ireland site. You will prepare, execute and report CSV deliverables, ensuring regulatory compliance and maintaining the validated state of GxP systems.

Responsibilities include coordinating end-to-end project activities, supporting audits, and contributing to QMS actions while training cross-functional teams on CSV procedures.