Automation / CSV Engineer

CAI; Ireland; Vor Ort; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CSV & Validation

SDLC & Validation

GMP & Regulatory

Stakeholder Management

Problem Solving

Hands-on Commissioning

Ausbildung

Engineering/Automation/CS degree

Tools

Siemens

Rockwell

DeltaV

Kneat

Jobbeschreibung

At CAI, we are passionate about delivering excellence in life sciences. Our teams work at the forefront of pharmaceutical and biotechnology projects, supporting the delivery of innovative manufacturing facilities and critical production systems that bring life-changing therapies to patients around the world.

We are currently seeking an experienced CSV / Automation Engineer to support a major manufacturing project during a critical commissioning and qualification phase.

Location: Boxmeer, Netherlands
Duration: 12 Month Contract
Start: ASAP

Why This Opportunity?

This role offers the chance to work on a high profile project where you will have genuine ownership and visibility across automation, digital systems, commissioning, qualification and validation activities.

You will join a collaborative project team and work closely with engineering, automation, validation and vendor partners to ensure critical systems are delivered compliantly and ready for operation.

This position is ideal for someone who enjoys combining technical automation knowledge with hands on validation and project delivery activities.

What You'll Be Doing

• Lead and support Computer System Validation (CSV) activities for GMP regulated automation and digital systems.
• Review and assess automation and digital system deliverables throughout the project lifecycle.
• Develop and execute validation documentation including protocols, reports and risk assessments.
• Support commissioning, startup and qualification activities for automated equipment and systems.
• Participate in FAT, SAT and field testing activities.
• Collaborate with equipment vendors, engineering teams and internal stakeholders to ensure compliant system delivery.
• Assess system changes and support change control activities.
• Ensure compliance with GMP, Data Integrity, GAMP and regulatory requirements.
• Support the integration of new equipment and systems into the site's digital landscape.

What We're Looking For

Required:

• Degree in Engineering, Automation, Computer Science or a related technical discipline.
• 5+ years' experience within Computer System Validation, Automation Validation, CQV or Digital Manufacturing projects.
• Strong understanding of the system development lifecycle (SDLC) and validation methodologies.
• Experience delivering validation activities for GMP manufacturing systems.
• Knowledge of GMP, GAMP 5, Data Integrity and relevant regulatory requirements.
• Hands-on experience supporting commissioning and qualification activities.
• Strong stakeholder management and problem-solving skills.
• Applicants must have existing authorisation to work in the Netherlands. Unfortunately, sponsorship or visa support is not available for this opportunity.

Highly Desirable:

• Experience with PLC, SCADA and/or DCS systems.
• Automation platform experience such as Siemens, Rockwell, DeltaV or similar.
• FAT and SAT execution experience.
• Experience with electronic validation systems such as Kneat.
• Equipment integration experience within pharmaceutical or biotechnology manufacturing facilities.

At CAI, our people are our greatest asset. We offer the opportunity to work on challenging projects, collaborate with industry leading professionals and make a meaningful impact within the life sciences sector.

If you are looking for your next challenge and want to be part of an exciting project in the Netherlands, we'd love to hear from you.