Senior GMP CSV Automation & Validation Engineer

CAI; Ireland; On-site; EUR 65,000 - 95,000; Full time

Job summary

CAI is seeking an experienced CSV/Automation Engineer to support a major manufacturing project during commissioning and qualification. Based in the Netherlands, you’ll take ownership of CSV activities, review deliverables, and develop validation documentation for GMP systems.

You will collaborate with engineering, validation and vendor partners to ensure compliant system delivery, support FAT/SAT, and drive successful qualification and commissioning across the site.

Qualifications

• Degree in Engineering, Automation, Computer Science or related field.
• 5+ years in CSV/Automation/CQV or digital manufacturing projects.
• Knowledge of SDLC and validation methodologies.
• Experience delivering validation for GMP manufacturing systems.
• Knowledge of GMP, GAMP5, Data Integrity and regulatory requirements.
• Hands-on commissioning and qualification activities.
• Strong stakeholder management and problem solving.
• Netherlands work authorization; no sponsorship provided.

Responsibilities

• Lead and support CSV activities for GMP automation and digital systems.
• Review automation deliverables across the project lifecycle.
• Develop and execute validation docs: protocols, reports, risk assessments.
• Support commissioning, startup and qualification of equipment.
• Participate in FAT, SAT and field testing activities.
• Collaborate with vendors, engineering teams and stakeholders.
• Assess system changes and support change control activities.
• Ensure compliance with GMP, Data Integrity and regulatory requirements.

Skills

CSV & Validation

SDLC & Validation

GMP & Regulatory

Stakeholder Management

Problem Solving

Hands-on Commissioning

Education

Engineering/Automation/CS degree

Tools

Siemens

Rockwell

DeltaV

Kneat

Job description

CAI is seeking an experienced CSV/Automation Engineer to support a major manufacturing project during commissioning and qualification. Based in the Netherlands, you’ll take ownership of CSV activities, review deliverables, and develop validation documentation for GMP systems.

You will collaborate with engineering, validation and vendor partners to ensure compliant system delivery, support FAT/SAT, and drive successful qualification and commissioning across the site.