CSV Engineer

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

Haarlem, Netherlands | Posted on 09/01/2026

• Objective: Provide Computer System Validation (CSV) leadershipand support for capital projects, ensuringall automated and computerized systems are implemented, qualified, andvalidated in compliance with quality standards, GAMP5, SDLCmethodology, and applicable regulatory requirements .
  
• Engagement Type: Time-and-materials
  

Scope and Core Responsibilities

• Serve as the Computer SystemValidation (CSV) Subject Matter Expert (SME) for capital projects.
• Provide a standardized CSV approach acrossprojects in alignment with the CSV Lead's validation strategy.
• Work closely with Automation, IT, Quality,Engineering, and teams responsible for system delivery andimplementation.
• Collaborate with vendors,suppliers, and system integrators to ensure compliance with validation andquality requirements.
• Develop and maintain Qualification Plans,Validation Plans, and Test Plans aligned with project Commissioning &Qualification (C&Q) strategies.
• Develop, review, and approve SoftwareDevelopment Lifecycle (SDLC) deliverables, including :
• Requirements Traceability Matrices (RTM)
• Test Specifications and Test Scripts
• Validation Summary Reports
• Other qualification and validation documentation as required
• Ensureall CSV deliverables comply with quality procedures, GAMP5 guidance, SDLCrequirements, and applicable regulatory standards.
• Partner with Digital Data &Quality (DDQ) teams to ensure all data integrity and compliance requirementsare addressed.
• Review vendor documentation and validationpackages to confirm compliance with standards and leveraging requirements.
• Provide Factory AcceptanceTesting (FAT) oversight and perform validation leveraging assessments.
• Support project teams with CSVguidance, document generation, review, and execution activities.
• Participate in project planningactivities and provide input into realistic project schedules and validationtrackers.
• Represent the CSV function atproject, automation, IT, quality, and stakeholder meetings.
• Facilitate communicationbetween project stakeholders regarding validation strategy, documentation,testing, and compliance requirements.
• Support regulatory inspections,audits, and quality reviews as required.
• Qualification Plans and TestPlans
• Requirements Specifications(URS/RS)
• Functional Specifications (FS)
• Design Specifications (DS)
• Requirements TraceabilityMatrices (RTM)
• Test Specifications and TestScripts
• Validation Summary Reports
• FAT Oversight Documentation andLeveraging Assessments
• SDLC Templates and ValidationDocumentation Standards
• Qualification and ValidationExecution Records
• Validation Schedules andDocument Trackers
• Risk Assessments and ComplianceAssessments
• Audit and Inspection SupportDocumentation
• Project Status Reports andStakeholder Updates
• Final Validation Approval and Project CloseoutDocumentation

Required Qualifications and Competencies

• Bachelor's Degree in Computer Science,Engineering, Automation, Information Technology, or related discipline.
• Minimum 3 years of ComputerSystem Validation experience within Life Sciences or PharmaceuticalManufacturing.
• Expert knowledge of GAMP5validation methodology.
• Strong understanding of SDLCprocesses and validation lifecycle requirements.
• Experience developing andexecuting validation documentation within GMP-regulated environments.
• Demonstrated experiencereviewing and approving validation deliverables.
• Experience working with vendorsand system integrators on regulated projects.
• Strong stakeholder management,communication, and technical writing skills.
• Ability to operate effectively withincross-functional project teams.