Business Operations Associate Jobs in Durham, NC

About Us

• We are a cGMP biomanufacturing organization focused on reliable, compliant, and efficient drug substance production.
• Our Digital Operations team partners closely with Manufacturing, Automation, and Quality to deploy and sustain recipe-driven operations and electronic batch execution.
• We value learning, collaboration, and continuous improvement—and we set our teams up for success with clear procedures, supportive leadership, and opportunities to build new skills.

Responsibilities

• Support deployment and sustainment of digital manufacturing tools (e.g., MES, data historians, electronic logbooks) by executing clearly defined tasks within established procedures.
• Assist with configuration activities for recipe-driven operations and prepare documentation for review and approval.
• Perform basic data collection, routine analysis, and system monitoring to help ensure consistent, reliable digital operations.
• Follow cGMP, data integrity, and compliance standards; escalate non-routine issues to senior team members.
• Contribute to user training by preparing materials, documenting standard work, and conducting walkthroughs under supervision.
• Participate in cross-functional coordination to support digital integration and electronic batch execution.
• Identify straightforward opportunities to streamline tasks or standard work and contribute to continuous improvement.
• Provide on-call support participation as scheduled, with guidance from senior staff.
• Maintain accurate records, logs, and status updates for assigned tasks.
• Perform other duties as assigned.

What you’ll bring (Minimum Qualifications)

• One of the following:
  • High School Diploma/GED with 4 years of related experience; or
  • Associate’s degree in Life Sciences or Engineering with 2 years of related experience; OR
  • Bachelor’s degree in Life Sciences, Engineering, Information Systems, or related field; OR
  • Equivalent practical experience with no prior experience
• Foundational knowledge of MES and electronic batch documentation, with the ability to learn digital manufacturing systems quickly.
• Understanding of cGMP principles and data integrity requirements; applies established procedures and standards.
• Strong attention to detail, organization, and time management; delivers accurate, timely work.
• Clear written and verbal communication; collaborates effectively and seeks feedback.
• Basic problem-solving skills and ability to apply standard techniques to routine issues, escalating when appropriate.
• Familiarity with manufacturing processes and cross-functional collaboration.
• Willingness to support a 24/7 manufacturing environment as needed, including rotational on-call.

Preferred Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• Experience (internship/co-op/project) supporting digital manufacturing systems (e.g., MES, PI/data historian, DCS/PLC, LIMS, ERP integration).
• Familiarity with GMP/GLP requirements and biological manufacturing environments.

Benefits

• Competitive compensation with opportunities for growth and skill development.
• Comprehensive health and wellness coverage for you and your family.
• Retirement savings plan with company support.
• Paid time off, holidays, and leave programs.
• Training, mentorship, and learning opportunities to accelerate your development in digital manufacturing.
• Potential hybrid work flexibility depending on role and site needs.
• Inclusive, collaborative culture that values diverse perspectives and ensures equitable opportunities.
• Meaningful work that supports compliant, reliable drug substance manufacturing.

Accessibility and Work Environment

• This role supports a 24/7 manufacturing environment and includes rotational on-call participation.
• Work may include time in mechanical/production areas with standard safety requirements and use of powered industrial trucks.
• Ability to sit for up to 60 minutes at a time, stand for up to 30 minutes at a time, operate machinery, and occasionally move objects up to 33 lbs; ability to discern audible cues and work with corrected vision as needed.
• We are committed to providing reasonable accommodations throughout the application and employment process. If you need assistance, please let us know.

If you’re eager to grow your career in digital manufacturing and contribute to reliable, compliant operations, we’d love to hear from you. Apply today.

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.