CSV Validation Engineer - GMP Pharma Compliance

Leap29; Ireland; On-site; EUR 65,000 - 90,000; Full time

Job summary

Leap29 seeks a mid-level CSV Engineer to support GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. The role emphasizes hands-on execution of CSV lifecycle activities, collaborating with Quality, Engineering, IT, and project teams to ensure compliance and timely project delivery.

The successful candidate will prepare documentation such as Validation Plans, IQ/OQ/PQ, risk assessments, and final reports, applying risk-based validation approaches for

Qualifications

• Strong understanding of CSV requirements and project delivery.
• Experience with GMP computerized systems in pharma/biopharma.

Responsibilities

• Execute CSV lifecycle activities for GMP systems (MES, DCS, SCADA).
• Prepare and support Validation Plans, IQ/OQ/PQ, URS, Risk Assessments, final reports.
• Apply risk-based validation approaches for new and existing systems.
• Ensure compliance with cGMP, GAMP 5, Annex 11, and 21 CFR Part 11.
• Review specifications and qualification records; support audits and deviations.

Skills

CSV regulatory knowledge

GAMP 5 understanding

21 CFR Part 11 knowledge

Validation lifecycle execution

Documentation & reports

Risk assessments

CAPA investigations

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Life Sciences/CS

Job description

Leap29 seeks a mid-level CSV Engineer to support GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. The role emphasizes hands-on execution of CSV lifecycle activities, collaborating with Quality, Engineering, IT, and project teams to ensure compliance and timely project delivery.

The successful candidate will prepare documentation such as Validation Plans, IQ/OQ/PQ, risk assessments, and final reports, applying risk-based validation approaches for