Manufacturing Associate 5, Upstream

Fujifilm • Holly Springs, NC

15h • Onsite

About The Position

The Manufacturing Associate 5, Upstream, leads and executes manufacturing processing steps and related activities, and assists the supervisor as needed. During the project phase, the role supports operational readiness for bulk drug substance manufacturing, including equipment commissioning and qualification, procedure review or creation, onboarding manufacturing staff, development or transfer of manufacturing business processes, new item creation, and transfer or design of single-use assemblies. Travel of 0–25% may be required, domestically and/or internationally.

In operations, the associate performs and documents manufacturing steps and support activities, monitors and controls processes, and ensures compliance with SOPs and cGMP regulations. The role includes performing or overseeing in-process tests, executing validation protocols, maintaining required training, mentoring junior associates, supporting daily floor scheduling, and providing backup approval and supervisory support. The associate also leads troubleshooting, supports shift huddles, tier escalations, investigations and continuous improvement projects, and leads cycle counts and materials management in the assigned area. The facility operates 24/7; this role requires shift work, including weekends and potentially nights, and may require flexibility with hours and rotating shifts.

Requirements

• 8 years of experience in life sciences manufacturing with a high school diploma or GED, or 6 years with an associate degree, or 4 years with a bachelor's degree, or equivalent military experience.
• 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 abilities.
• Team-based approach and ability to work in a global team environment by building relationships and communicating effectively.
• Ability to work shifts, including weekends and potentially nights.
• Ability to work in an environment that may require respiratory protection.
• Ability to work in mechanical or production spaces that may require hearing protection and participation in a hearing conservation program.
• Ability to discern audible cues.
• Ability to ascend or descend ladders, scaffolding, ramps, and similar structures.
• Ability to stand and sit for prolonged periods.
• Ability to perform repetitive motions involving the wrists, hands, and/or fingers.
• Ability to move objects up to 33 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18 to 60 inches in height, and use twisting motions.
• Ability to work at heights greater than 4 feet.

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.
• Fully qualified in a functional area, such as drug product formulation and filling, weigh and dispense, cell culture, or purification, and acting as a subject matter expert on all unit operations in that functional area.
• BioWorks Certification.

Responsibilities

• Support operational readiness for 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 support activities, including process monitoring and control, in compliance with SOPs and cGMP regulations.
• Oversee and/or perform in-process testing, including pH, conductivity, and visual inspection.
• Execute validation protocols.
• Provide approval as a backup to the supervisor.
• Maintain training required to perform assigned activities.
• Train and mentor junior manufacturing associates.
• Support scheduling daily activities on the manufacturing floor and act as a backup for the supervisor as needed.
• Lead troubleshooting of operational issues as required.
• Assist the supervisor with shift huddles, tier escalations, investigations, and continuous improvement projects as needed.
• Lead area 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