Digital Operations Associate, Solutions

Fujifilm•Holly Springs, NC

About The Position

The Digital Operations Associate supports deployment and sustainment of digital manufacturing tools for cGMP drug substance production, including MES, data historians, and electronic logbooks. Working with Manufacturing, Automation, and Quality, the role supports recipe-driven operations and electronic batch execution by carrying out defined tasks within established procedures. The position is an entry point for building skills in digital manufacturing in a collaborative environment focused on reliable, compliant, and efficient operations. The role includes basic configuration support, documentation preparation, data collection and routine analysis, system monitoring, training support, cross-functional coordination, and continuous-improvement contributions. The associate follows cGMP and data-integrity standards and escalates non-routine issues to senior team members. Rotational on-call participation may be required in support of a 24/7 manufacturing environment. The work may include time in mechanical or production areas, use of powered industrial trucks, and compliance with standard safety requirements. Reasonable accommodations are available throughout the application and employment process.

Requirements

  • One of the following: high school diploma/GED with 4 years of related experience; associate’s degree in Life Sciences or Engineering with 2 years of related experience; bachelor’s degree in Life Sciences, Engineering, Information Systems, or a 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, and ability to apply established procedures and standards.
  • Strong attention to detail, organization, and time management, with the ability to deliver accurate, timely work.
  • Clear written and verbal communication skills; ability to collaborate effectively and seek feedback.
  • Basic problem-solving skills and ability to apply standard techniques to routine issues and escalate when appropriate.
  • Familiarity with manufacturing processes and cross-functional collaboration.
  • Willingness to support a 24/7 manufacturing environment as needed, including rotational on-call.

Nice To Haves

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

Responsibilities

  • Support deployment and sustainment of digital manufacturing tools, including MES, data historians, and electronic logbooks, by performing 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 support consistent, reliable digital operations.
  • Follow cGMP, data-integrity, and compliance standards, and escalate non-routine issues to senior team members.
  • Support user training by preparing materials, documenting standard work, and conducting walkthroughs under supervision.
  • Participate in cross-functional coordination supporting digital integration and electronic batch execution.
  • Identify straightforward opportunities to streamline tasks or standard work and contribute to continuous improvement.
  • Participate in scheduled on-call support with guidance from senior staff.
  • Maintain accurate records, logs, and status updates for assigned tasks.
  • Perform other duties as assigned.

Benefits

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