Senior CSV Engineer

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

Senior CSV Engineer | €1bn+ Greenfield Biopharmaceutical Project | 1 Day Onsite

Imagine joining a project so significant that it will redefine biopharmaceutical manufacturing for years to come.

We're supporting a global biopharmaceutical organisation delivering a €1 billion+ greenfield facility, with investment and expansion planned through to 2032. This is an opportunity to play a key role from the client side, shaping the validation strategy for one of the most technologically advanced manufacturing sites in Europe.

What makes this opportunity even more attractive is the flexibility on offer, with just one day per week onsite, allowing you to contribute to a landmark project without sacrificing work-life balance.

Having already placed several Automation Leads, Senior CSV Engineers and Project Managers into the programme, we've received exceptional feedback regarding the calibre of the team, long-term vision, and commitment to investing in cutting‑edge digital manufacturing technologies.

Why This Role?

• Join a flagship €1bn+ biopharmaceutical capital investment project
• Work client‑side with genuine influence over project delivery
• Hybrid working with only 1 day onsite per week
• Long‑term programme extending through 2032
• Opportunity to remain onsite and support future digital transformation initiatives
• Collaborate with industry‑leading automation, CQV and quality professionals

The Opportunity

As Senior CSV Engineer, you'll be a key member of the automation and validation team, taking ownership of computer systems validation activities across critical GMP manufacturing systems.

You'll work closely with Automation, CQV, Quality, Engineering and vendor partners to ensure systems are delivered compliantly, efficiently, and ready for operational excellence from day one.

Key Responsibilities

• Lead the authoring, review and execution of validation lifecycle documentation 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

What We're Looking For

• 8+ years' experience in Computer Systems Validation within pharmaceutical, biopharmaceutical or regulated manufacturing environments
• Strong understanding of automation platforms, PLCs and manufacturing control systems
• Proven experience authoring and executing FAT, SAT, IQ/OQ and CSV documentation
• Extensive knowledge of GAMP 5, SDLC, Annex 11 and 21 CFR Part 11
• Experience working within GMP-regulated environments
• Exposure to systems such as MES, PI Historian, PCS, Laboratory Systems, QMS or related manufacturing technologies
• Strong stakeholder management and communication skills
• Experience with paperless validation platforms such as Kneat would be advantageous

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