Manufacturing Associate 4, Upstream

Fujifilm•Holly Springs, NC
•Onsite

About The Position

FUJIFILM Biotechnologies is hiring a Manufacturing Associate 4 to assist with executing and documenting manufacturing processing activities in a cGMP environment. The role supports project-phase readiness and steady-state operations in a 24/7 facility, helping maintain safe, consistent, and efficient production. Flexibility with working hours and shift rotations is required. The role leads and performs complex manufacturing processing and support activities within an assigned functional area. It ensures activities are completed and documented according to SOPs and cGMP requirements, and supports operational readiness, process transfer, procedure creation, equipment testing, commissioning, and validation. The associate performs process monitoring and in-process testing, contributes to materials management, and provides advanced equipment and process knowledge within qualified unit operations. The associate also guides and trains less-experienced manufacturing associates, leads or supports troubleshooting, and helps senior associates and supervisors coordinate daily floor activities. Potential safety, quality, documentation, and operational concerns are identified and escalated appropriately.

Requirements

  • High school diploma or GED and 6 years of life sciences manufacturing experience; or an associate degree and 4 years of life sciences manufacturing experience; or a bachelor’s degree and 2 years of life sciences manufacturing experience; or equivalent military training or experience.
  • Strong troubleshooting and technical documentation skills.
  • Ability to train, guide, and provide technical support to other associates.
  • Advanced understanding of manufacturing cadence and shift activities.
  • Advanced knowledge of production equipment and assigned unit operations.
  • Strong time-management skills and ability to adjust to changing priorities.
  • Flexibility with working hours and shift rotations.
  • Ability to work at heights greater than 4 feet and in environments that may necessitate respiratory protection.
  • Ability to discern verbal cues and sit or stand for prolonged periods.
  • Ability to ascend or descend ladders, scaffolding, ramps, and similar structures.
  • Ability to move objects weighing up to 33 pounds.
  • Ability to perform repetitive tasks using wrists, hands, and/or fingers.
  • Ability to bend, push or pull, reach to retrieve materials from 18–60 inches in height, and use twisting motions.
  • May work in mechanical or production spaces that require hearing protection and enrollment in a hearing conservation program.

Responsibilities

  • Lead and execute complex manufacturing processing and support activities within an assigned functional area.
  • Ensure manufacturing activities are completed and documented according to SOPs and cGMP requirements.
  • Support operational readiness, process transfer, procedure creation, equipment testing, commissioning, and validation.
  • Perform process monitoring and in-process testing.
  • Assist with cycle counts and materials management.
  • Guide and train less-experienced manufacturing associates.
  • Lead or support troubleshooting of manufacturing and operational issues.
  • Support senior associates and supervisors with coordinating daily floor activities.
  • Provide advanced equipment and process knowledge within qualified unit operations.
  • Identify potential safety, quality, documentation, or operational concerns and escalate them appropriately.
  • Perform other duties as assigned.
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