Automation / CSV Engineer

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.

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.

• →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.

• 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.

• 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.