Lead CSV Engineer for Life Sciences Validation

Horizon Controls Group; Haarlem; On-site; EUR 70,000 - 100,000; Full time

Job summary

Horizon Controls Group in Haarlem, Netherlands, seeks a Computer System Validation (CSV) lead to oversee capital projects, ensuring all automated systems are qualified, implemented, and compliant with quality standards and regulatory requirements.

You will standardize CSV approaches, partner with DDQ teams, and manage SDLC deliverables while coordinating with cross-functional teams and vendors to ensure robust validation programs.

Qualifications

• Expert knowledge of GAMP5 validation methodology.
• Strong SDLC and validation lifecycle understanding.
• Experience developing GMP-regulated validation documentation.
• Proven ability to review and approve validation deliverables.
• Experience collaborating with vendors and system integrators on regulated projects.
• Excellent stakeholder management and technical writing skills.

Responsibilities

• Serve as CSV SME for capital projects and standardize CSV approach.
• Collaborate with Automation, IT, Quality, Engineering teams for delivery.
• Review vendor documentation and validation packages for compliance.
• Provide FAT oversight and validation leveraging assessments.
• Develop and maintain Validation Plans, Test Plans, and RTMs.
• Represent CSV in project meetings and coordinate schedules

Skills

CSV leadership

GAMP5 knowledge

SDLC understanding

Regulatory compliance

Documentation writing

Vendor coordination

Education

Bachelor's degree in a relevant field

Job description

Horizon Controls Group in Haarlem, Netherlands, seeks a Computer System Validation (CSV) lead to oversee capital projects, ensuring all automated systems are qualified, implemented, and compliant with quality standards and regulatory requirements.

You will standardize CSV approaches, partner with DDQ teams, and manage SDLC deliverables while coordinating with cross-functional teams and vendors to ensure robust validation programs.