The primary focus of the Environmental, Health, and Safety (EHS) Manager will be to support the development, optimization and implementation of CARsgen US Environmental Occupational Health, Safety and Sustainability Standards at CARsgen labs and facilities in the United States. This role reports directly to the Director of Engineering at the site.
Key Responsibilities
· Lead the development and maintenance of CARsgen RTP Standard Operating Procedures, site Work Instructions, and plans to help ensure continued improvement of facility and organization EHS performance.
· Manage the provision of EH&S services including gap assessments, risk assessments (PHA or others), training, policy/SOP development and implementation, ergonomic evaluations, routine site inspections, and other services as required.
· Support implementation of incident and near miss reporting and investigation process, ensures communication to appropriate management, and/or implementation of necessary preventive measures.
· Document control and tracking – Manage all EHS documents (protocols, manuals, work instructions, Safety Committee Meeting Minutes, etc.) to ensure they are maintained within proper CARsgen repository for access and training.
· Assist with the management of EHS inspections, including scheduling, documenting and Corrective and Preventative Action Plan completion records
· Support Industrial Hygiene Program as needed, including calibration program for instruments
· Training Program – Responsible for the management and deployment of EHS training content within company learning platform.
· Leads the day-to-day activities of all EHS Programs including, Industrial Hygiene, Environmental, Occupational Health, Hazardous Waste Management, Emergency Response Plan and Crisis Management.
· Responsible for annual precursor licensing and registration activities
· Leads management of site Emergency Response Team and reports any off-site spills or releases to appropriate parties
· Lead the management of EHS PPE deployment programs such as safety footwear and prescriptions safety glasses
· Lead the development and reporting of key EHS metrics
· Schedule and coordinate Ergonomic Assessments as needed for employees. Manage any required follow up equipment or tools to ensure end customer satisfaction
· Develop and deploy EHS communications using existing media display tools to enhance EHS program effectiveness
· Act as liaison with Facilities, Lab Services, and Research departments to facilitate design and implementation of site projects with EHS impacts.
· Create and deploy EHS surveys to gauge EHS program effectiveness
· Lead tracking and coordination of EHS permit renewals, regulatory deadlines, training requirements and other internal compliance timelines.
· Lead the administration of contractor safety program and associated SAFE Work Permits, Job Hazard Analysis, and any required documentation.
· Lead the review, development, and maintenance of EHS manuals, work practices, SharePoint site and other resources.
Qualifications & Experience
· Bachelor’s degree in safety or environmental sciences related field, chemistry, biology, or closely related scientific field with 5-7 years of pharmaceutical industry experience; EHS training or certifications such as ASP, CSP, CIH, CHMM a plus
· Working knowledge and understanding of current applicable federal, state, and local environmental health and safety regulations and procedures that apply to the biotech industry.
· Ability to develop proactive programs effectively, resolve issues, and make recommendations to enhance existing programs.
· Customer facing role, must be able to communicate professionally and effectively with colleagues regarding EHS protocols.
· Demonstrates effective project management skills; managing multiple projects/tasks, prioritization, organization, communication to stakeholders, and meeting project deadlines.
· Experience using EHS management platform software for incident reporting, inspections, and self-assessments very beneficial
· Technical writing experience a plus
· Up to 10% travel required
· Knowledgeable with cGxP as well as regulatory requirements for cell therapy and pharmaceutical is a plus.