Sr Engineer 1

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

The Senior Engineer 1, EHS is responsible for leading the development and execution of Environmental, Health, Safety and Sustainability programs. This includes compliance with applicable regulations (Federal, State, Local), codes and standards. Serves as a subject matter expert (SME) and will collaborate with assigned functional operation areas to instill a world class culture of EHS. Additional responsibilities include support of EHS engagement programs (EHS observations, GEMBA), training, audits, inspections, investigations, and collaboration with EHS personnel across the organization.

What You'll Do

• Creates, executes, and oversees Environmental, Health and Safety (EHS) and Sustainability program areas (e.g., Lockout\Tagout, Confined Space,
• Motorized Vehicle, etc.)
• Supports development of Global EHS and Sustainability practices and standards
• Oversees and manages budget within a specified area of responsibility
• Serves as EHS single point of contact for assigned operational teams
• Drives functional area of responsibility with operations teams and contract engineering agents
• Leads innovation in collaboration with the design sustainability team to identify key environmental drivers, best in class, out of the box reduction solutions, and champion integration into the design
• Leads process hazard assessments (PHA) as EHS subject matter expert (SME) to identify points of concern, establish mechanisms of control, and ensure actions are both incorporated by design and meet intent during start-up
• Serves as EHS SME to ensure timely response to questions from process stakeholders
• Leads development of site permits and policies to start-up and operate facility
• Provides EHS and Sustainability orientation and training, as needed
• Mentors EHS associates or other colleagues
• Other duties, as assigned

Who You Are

You will be responsible for leading the development and execution of EHS and support development of Global EHS and Sustainability practices and standards.

Basic Requirements

• Bachelor's degree in Occupational, Industrial Health and Wellness, Industrial Hygiene, Public Health, Engineering, or related field with 8 years of experience in a pharmaceutical or manufacturing environment; OR
• Master's degree with 6 years of relevant experience
• Experience working extensively in multiple process areas
• Prior experience working proficiently with applicable codes & standards
• Effective communication, both written and oral
• Ability to represent company and collaborate with key internal and external stakeholders including regulators, insurance carriers and corporate auditors
• Proficient with EHS and/or Sustainability regulations within the pharmaceutical or other highly regulated industry
• Ability to interpret Piping and Instrumentation Diagrams (P&IDs) and other design documentation
• Expert proficiency in at least one EHS discipline

Preferred Requirements

• Prior experience in greenfield operations, advanced manufacturing, or start-up of new facilities
• Biopharmaceutical, Active Pharmaceutical Ingredient, finished Drug Product (DP) or Good Manufacturing Practices (GMP) experience OSHA 10\30
• HAZWOPER 40 Hour
• NIMS 400 (Incident Command)
• Associate Safety Professional (ASP) certification
• Certified Safety Professional (CSP)
• Certified Industrial Hygienist (CIH)
• Certified Hazardous Materials Manager (CHMM)
• Manager of Environmental, Safety and Health (MESH) certification

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Will work in environment which may necessitate respiratory protection X No Yes
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
• Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
• Ability to discern audible cues. No X Yes
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
• Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
• Ability to stand for prolonged periods of time. No X Yes 60 minutes
• Ability to sit for prolonged periods of time. No X Yes 60 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
• Ability to operate machinery and/or power tools. X No Yes
• Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes

FDBN 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. If an accommodation to the application process is needed, please email .

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.