We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
The Senior EH&S Specialist supports and implements FDBU Safety, Environmental, Health Programs. They are responsible for supporting programs that ensure compliance with local, state and federal regulations, as well as corporate policies. There are no staff to supervise, however committees to manage. The Senior EH&S Specialist interacts with the HLUS EHS organization and handles assignments as appropriate. This position reports to the Sr. Manager, EH&S.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Along with the Sr. Manger of Safety, Health, and Environmental ensure compliance with all EHS programs including required written programs, training, permits and regulatory reporting. Supports programs to increase safety, environmental and health awareness and encourage proactive measures are in place and sustained.
- Environmental – Wastewater Compliance, project evaluation for disposal of process wastewaters and buffers, Air Compliance, Hazardous and Non-Hazardous Waste Compliance. Specifically, managing on-site hazardous waste contractors ensuring program compliance. Ensuring corrective actions are taken.
- Safety – General Safety, Hazard Communication, Incident Reporting, Respiratory Protection, LOTO, Hearing Conservation. Including SDS management, noise monitoring, chemical air monitoring, fit testing, periodic inspections.
- Review safety data and trends, prepare reports for site, corporate and external groups, as needed.
- Review and analyze workplace hazards and provide recommendations to reduce or eliminate hazards.
- Schedules, develops and conducts employee training programs. Applies adult learning principles and company design methodology to training materials. Administer various functions within the site Learning Management System (LMS).
- Lead EHS investigations of all safety, health and environment incidents. Use root cause analysis tools and zoom out to prevent similar events. Use and management of electronic incident reporting and CAPA tracking system. Good computer skills to the system administrator.
- Support Occupational Health Nurse in MERT team membership and first aid responses and MERT team events (meetings, trainings).
- Ability to present to and interact with clients and regulatory representatives on EHS topics. Support regulatory audits/inspections.
- Support FUJIFILM Fit activities and Industrial Athleticism initiatives at FDBU sites.
- Administer various functions within the site Quality change control system.
- Minimum of Bachelor’s degree in life science, preferably Environmental Health plus 1-3 years directly related experience in managing safety, health and environmental programs at least one year should be in the pharmaceutical industry.
- Good working knowledge of OSHA, EPA and cGMP requirements or working within a highly regulated environment.
- Able to frequently walk and sit and stand. Occasionally required to reach, climb, balance, kneel, crouch or crawl, lift (not to exceed 50 pounds) and move drums of waste with a drum lifter. Ability to wear a full face respirator and PAPR respirator.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.