About this role
Your role
BioReliance Contract Testing Laboratories in Darmstadt is looking for a Senior Facility, EHS & Equipment Validation Expert to ensure that site facilities, critical utilities, laboratory equipment and EHS processes remain safe, compliant, reliable and fit for their intended use.
In this cross-functional role, you will combine technical expertise in facility and laboratory infrastructure with strong knowledge of environment, health and safety requirements and equipment qualification and validation. You will work closely with laboratory operations, Quality, Engineering, Facilities, Environmental Health & Safety, Validation, suppliers and external service providers.
The role is well suited to an experienced professional who enjoys working at the intersection of regulated laboratory operations, technical project delivery, compliance and continuous improvement. This role requires 100% on-site.
Key responsibilities
EHS responsibilities
- ✓Serve as a senior technical contact for environment, health and safety matters related to our GMP Contract Testing Laboratories
- ✓Support implementation and continuous improvement of site EHS programs in line with applicable German and European legal requirements and Merck standards.
- ✓Identify hazards and assess risks associated with laboratory activities, facility systems, equipment operation, maintenance and construction work.
- ✓Support the development of safe operating procedures, permits, risk assessments, contractor requirements and emergency-response arrangements.
- ✓Participate in EHS inspections, audits, incident investigations and follow-up activities.
- ✓Work with internal stakeholders and external specialists on occupational safety, hazardous materials, environmental protection, waste management, fire protection and emergency preparedness, as applicable to the site.
- ✓Monitor and support the timely completion of EHS actions, inspections, training and required documentation.
Facility and infrastructure management
- ✓Act as a subject-matter expert for facility systems supporting regulated laboratory and office operations.
- ✓Coordinate the operation, maintenance and continuous improvement of critical facility systems, utilities and building-related infrastructure in a GMP environment.
- ✓Coordinate internal and external service providers, contractors and maintenance partners, ensuring that work is performed safely, efficiently and in accordance with GMP requirements.
- ✓Maintain accurate technical documentation, asset information, maintenance records and relevant site procedures using BMRAM and SAP.
Equipment qualification and validation
- ✓Develop and review user requirements specifications, functional and design specifications, risk assessments, qualification plans, protocols, reports and related validation documentation.
- ✓Plan and execute or oversee commissioning, installation qualification, operational qualification and performance qualification activities, as appropriate.
- ✓Manage validation deviations, change controls, corrective actions and periodic reviews.
- ✓Collaborate with Quality and laboratory subject-matter experts to define acceptance criteria and confirm that equipment is fit for intended use.
- ✓Ensure that calibration, preventive maintenance, requalification and periodic review requirements are defined and maintained throughout the equipment lifecycle.
Who you are
- ✓University degree, technical degree or comparable qualification in engineering, natural sciences, biotechnology, pharmaceutical technology, environmental science, occupational safety or a related discipline.
- ✓Demonstrated experience with facility and laboratory infrastructure, equipment qualification and/or validation.
- ✓Solid understanding of qualification and validation principles, including risk-based approaches, lifecycle management, change control, deviations and CAPA.
- ✓Practical knowledge of EHS risk assessment, incident prevention, contractor safety and safe work practices.
- ✓Experience working with quality systems and controlled documentation in a GMP-regulated.
- ✓Fluent German and good professional English, both written and spoken.
- ✓Willingness to work on site in Darmstadt and, when required, to support inspections, maintenance activities or operational issues outside standard working hours.
- ✓Experience in a contract testing laboratory or other multi-client regulated service environment.
- ✓Knowledge of GMP and other relevant regulated laboratory requirements.
- ✓Experience with critical utilities, cleanrooms, HVAC, gases, temperature-controlled systems, laboratory support systems or biosafety-related infrastructure
- ✓Formal training or certification in occupational safety, environmental management, project management, validation or a related area.
- ✓Experience preparing for or supporting regulatory, customer or quality-system audits.
- ✓Familiarity with electronic quality-management, maintenance-management or asset-management systems.
Department: LS-AS-TG
Job evaluation: Expert 3
TA: Gap Rattimasakol