Manufacturing Associate 5, Upstream

Fujifilm • Holly Springs, NC

2d • Onsite

About The Position

The Manufacturing Associate 5, Upstream, will lead and execute manufacturing processing steps and related activities, and assist the supervisor as required. The position supports operational readiness for bulk drug substance manufacturing during the project phase, including equipment commissioning and qualification, procedure review or creation, onboarding manufacturing staff, developing or transferring manufacturing business processes, creating new items, and transferring or designing single-use assemblies. The role may require 0–25% domestic and/or international travel.

In operations, the associate leads, executes, and documents manufacturing processing and support activities, monitors and controls processes within a functional area, and ensures compliance with SOPs, cGMP regulations, and safety protocols. The role includes in-process testing, executing validation protocols, maintaining required training, mentoring junior associates, helping schedule floor activities, troubleshooting operational issues, and supporting shift huddles, escalations, investigations, continuous improvement projects, cycle counts, and materials management. The associate may provide backup approval and supervisor coverage as needed.

The facility operates 24/7. This role requires shift work, including weekends and potentially nights, and flexibility with working hours and shift rotation. The work environment may require respiratory and hearing protection, and may involve working at heights greater than four feet and in mechanical or production spaces.

Requirements

• 8 years of life sciences manufacturing experience with a high school diploma or GED, or 6 years with an associate degree, or 4 years with a bachelor's degree; equivalent military experience is also accepted.
• Strong troubleshooting ability.
• Strong verbal and written communication skills.
• Ability to adapt in a fast-paced, changing environment and adjust plans accordingly.
• Strong time-management skills and critical-thinking and problem-solving ability.
• Team-based attitude and ability to work in a global team environment while building relationships and communicating effectively.
• Ability to work shifts, including weekends and potentially nights, and to accommodate flexible hours and shift rotation.
• Ability to perform the physical demands of the role, including prolonged standing and sitting, climbing, repetitive hand and wrist motions, moving objects up to 33 pounds, and bending, pushing, pulling, reaching, and twisting.
• Ability to discern audible cues and work in environments that may require respiratory and hearing protection.

Nice To Haves

• Associate degree.
• Bachelor of Arts or Bachelor of Science degree, preferably in Life Sciences or Engineering.
• Proficient understanding of cGMP regulations and pharmaceutical industry standards.
• Full qualification in a functional area such as Drug Product Formulation and Filling, Weigh and Dispense, Cell Culture, or Purification, and subject-matter expertise across unit operations within that area.
• BioWorks Certification.

Responsibilities

• Support preparation for operational readiness related to bulk drug substance manufacturing during the project phase.
• Support equipment commissioning and qualification, procedure review or creation, manufacturing staff onboarding, manufacturing business process development or transfer, new item creation, and single-use assembly transfer or design.
• Adhere to safety protocols and contribute to a culture of safety in the manufacturing environment.
• Lead, execute, and document manufacturing processing steps and manufacturing support activities.
• Monitor and control processes within a functional area in compliance with SOPs and cGMP regulations.
• Oversee or perform in-process testing, including pH, conductivity, and visual inspection.
• Execute validation protocols and provide approval as a backup to the supervisor.
• Maintain training to perform all required activities.
• Train and mentor junior manufacturing associates.
• Support scheduling daily manufacturing-floor activities and act as a supervisor backup as needed.
• Lead troubleshooting of operational issues as required.
• Assist the supervisor with shift huddles, tier escalations, investigations, and continuous improvement projects as needed.
• Serve as area lead for cycle counts and materials management.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED