Beschreibung

For our client in Stein (AG) we are looking for a highly motivated
HSE Systems Coordinator / Biosafety Officer (temporary)
You ensure safe handling of biological agents and GMOs at the site and full compliance with Swiss biosafety legislation and relevant international standards. You act as the main biosafety expert for laboratories and production areas and as key contact to authorities.
Key Responsibilities
Develop, implement and monitor the site biosafety management system in line with ESV, SAMV, GTG and EU regulations
Ensure compliance with Biosafety Levels 1–4 in all relevant areas
Conduct biosafety risk assessments for biological agents and GMOs and define containment measures
Act as primary liaison with FOEN and cantonal authorities; prepare and submit notifications and permit applications
Plan and deliver biosafety trainings for employees
Perform biosafety inspections/audits and follow up on corrective actions
Provide expert consulting to research, production and site management teams
Profile
MSc/PhD in Biology, Microbiology, Biotechnology or similar scientific field
Several years of hands-on experience with biological agents in a regulated environment (e.g. pharma, biotech, BSL labs)
Strong knowledge of Swiss biosafety law (ESV, SAMV, GTG) and BSL 1–4 requirements
Experience in regulatory affairs and in direct communication with enforcement authorities
Ideally experience in GMP/GLP or chemistry/research environments
Skills & Competencies
Very good written and spoken German and English (French is an advantage)
Independent, structured and reliable working style
Assertive, strong consulting and stakeholder management skills
Ability to manage complexity and regulatory deadlines
Strong team player with high sense of responsibility jid8cab09fa jit0417a jiy26a