Senior Facility & EHS & Validation Engineer (all genders)

In this on-site role, you ensure that site facilities, critical utilities, laboratory equipment and EHS processes stay compliant, safe and fit for use within a GMP contract testing environment. You will bridge facilities, quality, engineering and safety functions to deliver validated equipment and reliable infrastructure. Your work supports regulated lab operations, continuous improvement and successful audits. You will lead with risk-based thinking to protect personnel and product quality while enabling efficient operations.

• Serve as senior technical EHS contact for GMP Contract Testing Laboratories
• Support implementation and improvement of site EHS programs aligned with German/European laws and Merck standards
• Identify hazards and assess risks for lab activities, facility systems and equipment operations
• Develop safe operating procedures, permits, risk assessments and emergency-response plans
• Participate in EHS inspections, audits and incident investigations
• Coordinate with internal and external stakeholders on occupational safety, hazardous materials, environmental protection and waste management
• Monitor completion of EHS actions, inspections, training and documentation
• Act as SME for facility systems supporting regulated lab and office operations
• Coordinate operation, maintenance and improvement of critical facility systems and utilities in GMP environment
• Manage service providers and maintenance partners ensuring GMP-compliant work
• Maintain technical documentation and asset information using BMRAM and SAP
• Develop and review URS, FDS, risk assessments, qualification plans and validation protocols
• Plan and oversee commissioning, IQOQ, PQ activities and validation documentation
• Manage validation deviations, change controls and CAPA
• Collaborate with Quality and lab SMEs to define acceptance criteria for equipment
• Ensure calibration, PM, requalification and periodic reviews throughout equipment lifecycle

• University degree or technical degree in engineering, natural sciences, biotechnology, pharmaceutical technology, environmental science or related field
• Experience with facility and laboratory infrastructure and equipment qualification/validation
• Strong understanding of qualification principles, risk-based lifecycle management, change control, deviations and CAPA
• Practical knowledge of EHS risk assessment, incident prevention and contractor safety
• Experience with GMP-regulated quality systems and controlled documentation
• Fluent German and professional English
• Willingness for on-site work in Darmstadt and after-hours support
• Experience in a contract testing laboratory or multi-client regulated environment
• Knowledge of GMP and relevant regulated laboratory requirements
• Formal training or certification in occupational safety, environmental management, project management, validation or related area
• Experience preparing for/regulatory, customer or quality-system audits
• Familiarity with electronic quality-management, maintenance-management or asset-management systems

• Cross-functional collaboration
• Strong communication
• Problem-solving mindset
• Facility and infrastructure management in GMP environments
• Equipment qualification and validation (IQ/OQ/PQ)
• Risk-based approaches and lifecycle management