Job Description

Are you looking for a new challenge? For our location Amsterdam we are looking for a(n) GMP Automation & Process Engineer.

The GMP Process Automation & Application Expert is responsible for ensuring the reliable, compliant, and efficient operation of software-controlled bioprocesses within a GMP-regulated manufacturing environment. This role combines software ownership with deep understanding of biotechnology processes, batch manufacturing principles, process control systems and manufacturing execution systems.

The position serves as the key interface between operation, engineering, automation, validation, and quality functions, ensuring that batch operations, cleaning, sterilization, changeover activities, and process improvements are implemented and maintained in accordance with GMP requirements.

The engineer acts as the technical owner of automation and software solutions, driving system lifecycle management, compliance, change control, and continuous optimization of critical production processes.

Job responsibilities

Software Ownership & Compliance

• Own GMP-critical automation and software systems throughout their lifecycle (GAMP category 4/5).
• Ensure systems remain compliant, validated, secure and fit for purpose.
• Manage changes, deviations, CAPAs, periodic reviews and validation activities.
• Define business, process and compliance requirements for future electronic batch execution and recipe management solutions.
• Prepare and maintain manufacturing process models and documentation to support future electronic recipe and batch execution strategies.

Manufacturing Process Support

• Provide expert support for batch manufacturing processes based on ISA-88 (IEC 61512-1) model framework.
• Ensure automation systems effectively support batch execution, cleaning, sterilization and changeover activities.
• Troubleshoot complex process and automation issues and drive sustainable solutions.

Continuous Improvement & Projects

• Lead automation and digitalization projects to improve process reliability, efficiency and compliance.
• Identify and implement improvements in manufacturing processes and control strategies.
• Support CAPEX investments, system upgrades and new technology implementation.
• Contribute to long-term digital manufacturing strategies and roadmap development.

Collaboration & Stakeholder Management

• Act as the key interface between Operation, Engineering, Quality, Validation and IT.
• Support audits, inspections, technology transfers and regulatory submissions as automation subject matter expert.
• Promote best practices and provide technical guidance on automation, batch control and GMP compliance.

Qualifications required

Education & Experience

• Bachelor/master’s degree in Biotechnology, Biochemical Engineering, Process Engineering, Automation Engineering, Electrical Engineering, Industrial Engineering, Pharmaceutical Technology or a related technical discipline
• 10+ years of experience in GMP-regulated (bio)pharmaceutical, biotechnology or process manufacturing industry
• Extensive experience with process automation, manufacturing control systems and software lifecycle management in regulated industries
• Strong understanding of ISA-88 (IEC 61512-1) model framework and their application in biopharmaceutical manufacturing batch-oriented processes
• Demonstrated experience as system owner or software owner for GMP-relevant automation systems, preferrable Emerson DeltaV experience and GMP manufacturing execution systems. Further literacy in systems and applications such as(DCS, recipe management and batch reporting systems)
• Thorough knowledge of GMP requirements, Computerized System Validation (CSV/CSA), data integrity principles, change control, deviation management, and CAPA processes
• Experience with bioprocess operations including batch execution, cleaning, sterilization, equipment changeover and process monitoring
• Experience managing automation-related projects and supporting qualification and validation activities throughout the system lifecycle
• Understanding of process technology used in biologics manufacturing, incl. upstream, downstream, media preparation, CIP/SIP and utility systems
• Knowledge of OT security and system lifecycle management for industrial automation environments is preferred
• Strong understanding of OPEX/CAPEX projects and continuous improvement initiatives
• Excellent command of English; Dutch is considered an advantage.
• Experience with MES concepts, Electronic Batch Records (EBR), Recipe Management and ISA-88 would be considered an advantage.
• Knowledge of common MES platforms such as PAS-X, PharmaSuite or equivalent systems is preferred.

Skills & Competencies

• Deep technical expertise in process automation, software ownership and GMP manufacturing operations
• Strong analytical and troubleshooting skills with the ability to resolve complex technical and operational challenges
• Ability to bridge the gap between Operations, Engineering, Automation, Validation and Quality functions
• Strong stakeholder management and communication skills across all organizational levels
• Structured, quality-focused and compliance-driven mindset
• Proactive, solution-oriented and able to prioritize effectively in a dynamic manufacturing environment
• Continuous improvement mindset with experience in Lean, Six Sigma or Operational Excellence methodologies
• Ability to lead cross-functional initiatives and drive change in a highly regulated environment.

What do we offer?

• Employment: A challenging and international position in a professional and informal working environment
• Compensation: Attractive salary, holiday allowance, home-office travel allowance, participation in the company's success, subsidized pension plan
• Work-life balance: Flexible working hours (where possible), 30 days of vacation
• Versatile development opportunities: Support for professional development

As an international company, we welcome the diversity of people. We consciously promote equal opportunities and a diverse, inclusive culture in our teams - this is what makes us successful.

We look forward to receiving your application!

Reference Code: 31297