CSV Specialist

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

Job Advertisement: CSV Engineer / Specialist

Location: Ireland
Contract: 12-month renewable contract

Overview

We are seeking a dedicated and experienced mid-level Computer System Validation (CSV) Engineer to join our team. This role involves supporting GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. The successful candidate will focus on the hands‑on execution of CSV lifecycle activities, collaborating closely with Quality, Engineering, IT, and project teams to ensure compliance and timely project delivery.

Key Responsibilities

• Execute CSV lifecycle activities for GMP computerized systems, including MES, DCS, SCADA, and automated equipment.
• Prepare and support CSV documentation such as Validation Plans, URS, Risk Assessments, IQ, OQ, PQ, and final reports.
• Apply risk-based validation approaches for both new and existing systems.
• Ensure compliance with cGMP, GAMP 5, Annex 11, and 21 CFR Part 11 regulations.
• Support project teams to align validation activities with delivery timelines.
• Participate in validation risk assessments and define testing scope.
• Review system specifications, design documents, and qualification records.
• Support deviation management, discrepancy resolution, and data integrity assessments.
• Assist with periodic system reviews, audits, and regulatory inspections.
• Support the development and maintenance of CSV and qualification SOPs.
• Collaborate with cross-functional and global CSV teams.
• Escalate quality or compliance risks as required.
• Adhere to EHS and site safety procedures during validation activities.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related discipline.
• 4–7 years of experience in Computer System Validation within the pharmaceutical or biopharmaceutical industry.
• Strong understanding of CSV regulations and quality expectations.
• Hands‑on experience validating GAMP Category 3, 4, and 5 systems.
• Proven experience executing validation protocols and managing validation documentation.
• Working knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelines.
• Experience supporting investigations, root cause analysis, and CAPAs.
• Strong documentation skills and the ability to collaborate effectively across functions.