Manufacturing Associate - Biologics (Multiple Openings) - NIGHT SHIFT

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven Manufacturing Associates at several levels to join our Drug Substance production teams on a night shift (approximately 6:00 PM – 6:00 AM).

About the role

You will execute manufacturing processing steps and associated activities during operational phases, participate in operational readiness projects, and support commissioning/qualification projects. Our facility operates 24/7, with teams working 12-hour shifts on a 2-2-3 calendar rotation.

Responsibilities

• During the project phase:
  • Participate in and support testing activities (e.g., Factory Acceptance Testing, Performance Qualification).
  • Contribute to the preparation of documentation packages, including Standard Operating Procedures (SOPs) and Work Instructions.
  • Support operational readiness for Weigh and Dispense, bulk Drug Substance, or Drug Product manufacturing.
  • Assist with procedure review/creation, development or transfer of manufacturing business processes, and testing/commissioning support.
• Once operational:
  • Lead, execute, and document manufacturing processing steps and/or support activities, including process monitoring and control.
  • Perform operations within your functional area and execute validation protocols according to cGMP SOPs.
  • Own or establish processes and trainings, and serve as a trainer for coworkers.
  • Maintain compliance of GMP documents and ensure your training is up to date.
  • Support senior associates or supervisors with scheduling daily activities for your functional area, as needed.
  • Perform other duties as assigned.

Requirements

We are hiring for multiple levels of Manufacturing Associates:

• Manufacturing Associate 2:
  • High School Diploma or GED with 2 years of related experience in Life Sciences Manufacturing, or
  • Associate's Degree in Life Sciences with 0 years of related experience, or
  • Equivalent Military training/experience.
• Manufacturing Associate 3:
  • High School Diploma or GED with 4 years of related experience in Life Sciences Manufacturing, or
  • Associate's Degree with 2 years of experience in Life Sciences Manufacturing, or
  • BA/BS in Life Sciences with 0 years of experience, or
  • Equivalent Military training/experience.
• Manufacturing Associate 4:
  • High School Diploma or GED with 6 years of experience in Life Sciences Manufacturing, or
  • Associate's Degree with 4 years of experience in Life Sciences Manufacturing, or
  • BA/BS with 2 years of experience in Life Sciences Manufacturing, or
  • Equivalent Military training/experience.
• Manufacturing Associate 5:
  • High School Diploma or GED with 8 years of experience in a Life Sciences Manufacturing environment, or
  • Associate's Degree with 6 years of experience in a Life Sciences Manufacturing environment, or
  • BA/BS, preferably in Life Sciences/Engineering, with 4 years of experience in Life Sciences Manufacturing, or
  • Equivalent Military experience.

Working Conditions & Physical Requirements

• Work in environments that may require respiratory protection.
• Exposure to noisy environments.
• Normal range of vision required.
• Climb ladders and stairs of various heights.
• Prolonged sitting, standing, walking, bending, stooping, and stretching for up to 12-hour shifts.
• Hand-eye coordination and manual dexterity sufficient to operate office equipment (e.g., computer, telephone, calculator).
• Occasional lifting of up to 50 pounds.

About the location

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, offering the perfect blend of community and opportunity.