We are supporting a growing biopharmaceutical manufacturing organisation as they prepare a GMP site for operational readiness. We are looking for an HSE Manager to build and lead the site health, safety and environmental framework from project phase into routine GMP operations.
This role will be responsible for establishing practical HSE systems across laboratories, cleanrooms, utilities, technical areas, maintenance, contractors and future manufacturing operations.
Responsibilities
- Build and implement the site HSE management system for a GMP biopharmaceutical facility.
- Lead occupational safety, environmental protection, fire safety coordination, chemical safety, contractor safety and emergency preparedness.
- Ensure compliance with relevant German HSE requirements including ArbSchG, ASiG, BetrSichV, GefStoffV, DGUV, TRGS/TRBS and AwSV.
- Support site readiness across labs, cleanrooms, utilities, maintenance workshops, warehouse areas and manufacturing suites.
- Develop HSE policies, SOPs, risk assessments, permits, training plans, inspection routines and incident reporting processes.
- Support commissioning, qualification, start-up and handover activities from an HSE perspective.
- Partner with Engineering, CQV, Quality, Manufacturing, MS&T, Facilities, Utilities and external contractors.
- Manage HSE risks linked to bioreactors, chromatography systems, filtration, CIP/SIP, clean utilities, process gases, chemicals and biological materials.
- Lead investigations for incidents, near misses, unsafe conditions and environmental events.
- Drive CAPAs, corrective actions and continuous improvement across site safety performance.
- Manage hazardous substances, SDS systems, PPE standards, waste handling, environmental permits and emergency response planning.
- Lead contractor safety for construction, installation, maintenance and service activities.
- Prepare the site for audits, inspections and future operational HSE maturity.
- Promote a strong safety culture across a fast-growing technical organisation.
Requirements
- HSE management experience within pharmaceutical, biotech, chemical, biologics, life sciences or regulated manufacturing.
- Strong knowledge of German occupational safety and environmental regulations.
- Experience supporting site start-up, construction-to-operations handover, commissioning, qualification or GMP operational readiness.
- Good understanding of laboratory, cleanroom, utilities, maintenance and manufacturing safety risks.
- Experience with chemical safety, hazardous substances, risk assessments, incident investigations, CAPAs and contractor management.
- Knowledge of environmental topics such as waste handling, water protection, emissions, energy, spill control and hazardous material storage.
- Ability to work cross-functionally with Engineering, Quality, Manufacturing, CQV, Facilities, Utilities and external vendors.
- Practical, hands-on mindset with the ability to build systems from an early-stage environment.
- Strong communication and influencing skills across technical and non-technical teams.
- German and English language skills required.
#HSE #EHS #Biopharmaceutical #GMP #SiteReadiness #Sifa #ArbSchG #ASiG #BetrSichV #GefStoffV #DGUV #TRGS #AwSV #ChemicalSafety #LaboratorySafety #IncidentInvestigation #EmergencyResponse #Environmental #Safety #Occupationalsafety