| Location | Dublin, Ireland |
|---|---|
| Business Sector | Biotechnology |
| Contact email | |
| Job ref | 26862 |
| Published | about 5 hours ago |
Dublin / Craigavon – 12 months
As a CSV Engineer, you will join a specialized team dedicated to safeguarding data integrity and accelerating reliable manufacturing for life-changing therapies. You will shape the digital backbone of GMP operations, driving compliant performance across critical systems that ensure vital treatments reach patients safely.
In this role, you will turn complex regulations into practical testing strategies and risk-based validation, guiding teams across API manufacturing, pharmaceutical development, and commercial packaging. Your expertise will simplify qualification processes, strengthen data integrity, and reduce the time required to implement new equipment and systems while maintaining the highest standards of quality.
Education: Degree in Engineering, Computer Science, Life Sciences, or a related field.
Experience: Proven track record overseeing and performing computer system validation (CSV) activities within a GMP environment.
Core Technical Expertise: Subject matter expertise in validation for GMP manufacturing systems, specifically MES and DeltaV.
Required Hands-on Skills: Proven GMP documentation & technical writing capability, drafting/approving validation reports, and managing protocol discrepancies or deviations.
Required Scientific/Technical Knowledge: Deep understanding of GAMP 5, cGMP, and 21 CFR Part 11; ability to lead Validation Risk Assessments and conduct periodic system reviews.
Additional Experience: Experience in biopharmaceutical manufacturing environments and involvement in inspection readiness or mock audits.
Advanced Technical Skills: Hands-on familiarity with MES recipe management, DeltaV configuration, and change control.
Specific Technologies: Exposure to CAPA processes and automated governance tools.
Industry/Domain Exposure: Strong understanding of data integrity frameworks and audit trail review.
Soft Skills: Continuous improvement mindset (Lean or Six Sigma) and strong cross-functional stakeholder engagement skills.
Start Date: 1 April 2026
Contract Duration: 12 months (with performance-based extension)
Location: Dublin/Craigavon
Additional: This role involves supporting candidate snapshots and system evaluations; please ensure all technical documentation adheres to formal terminology.
Interviews and offers can move quickly. Send your CV to Oluali Titelman at o.titelman@panda-int.com or call +31 (0)20 2044 502 today to secure your spot in the process.