Senior CSV Engineer Hybrid, €1B Biopharma Project

NES Fircroft; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid working with 1 day onsite per週

Job summary

NES Fircroft seeks a Senior CSV Engineer for a €1bn+ greenfield biopharmaceutical project in Ireland. You will shape the validation strategy for critical GMP systems and lead CSV activities across automation platforms, working closely with CQV, Quality and Engineering teams.

The role offers hybrid working with only one day onsite per week, supporting a landmark digital manufacturing programme extending through 2032.

Qualifications

• 8+ years in Computer Systems Validation within pharma or regulated manufacturing.
• Strong understanding of automation platforms, PLCs and manufacturing control systems.
• Experience authoring and executing FAT, SAT, IQ/OQ and CSV docs.
• Extensive knowledge of GAMP 5, SDLC, Annex 11 and 21 CFR Part 11.
• Experience in GMP-regulated environments.
• Exposure to MES, PI Historian, PCS, Lab Systems or related tech.
• Strong stakeholder management and communication skills.
• Paperless validation tools such as Kneat are advantageous.

Responsibilities

• Lead authoring, review and execution of validation lifecycle docs including Validation Plans, URS, FAT, IOQ, RTM and Summary Reports
• Drive CSV activities across automation systems, manufacturing equipment and production lines
• Support and oversee FAT and IOQ execution while ensuring protocol compliance and issue
• Ensure compliance with GAMP 5, EU Annex 11 and 21 CFR Part 11 requirements
• Maintain complete traceability across validation documentation and testing activities
• Identify project risks and recommend improvements to validation strategies and methodologies
• Partner with Quality, Engineering, CQV and external vendors to achieve project milestones
• Contribute to continuous improvement initiatives and best practice development across the programme

Skills

CSV Engineering

Regulatory Validation

GMP Experience

Stakeholder Management

Communication Skills

Tools

GAMP 5

Annex 11

21 CFR Part 11

Kneat

Job description

NES Fircroft seeks a Senior CSV Engineer for a €1bn+ greenfield biopharmaceutical project in Ireland. You will shape the validation strategy for critical GMP systems and lead CSV activities across automation platforms, working closely with CQV, Quality and Engineering teams.

The role offers hybrid working with only one day onsite per week, supporting a landmark digital manufacturing programme extending through 2032.