Manufacturing Associate 5, Upstream

Fujifilm•Holly Springs, NC

7h•Onsite

About The Position

The Manufacturing Associate 5, Upstream will lead and execute manufacturing processing steps and associated activities, and assist the supervisor as required. During the project phase, the role contributes to operational readiness for bulk drug substance manufacturing, including equipment commissioning and qualification, procedure review or creation, onboarding manufacturing staff, developing or transferring manufacturing business processes, new item creation, and single-use assembly transfer or design. Travel of 0–25% may be required, domestically and/or internationally. In operations, the associate works within a functional area to perform and document manufacturing processing and support activities, monitor and control processes, and ensure compliance with SOPs and cGMP regulations. The role includes in-process testing, validation protocol execution, troubleshooting, training and mentoring junior associates, and providing backup support to the supervisor. The position works shifts, including weekends and potentially nights, at a facility described as operating 24/7.

Requirements

Meet one of the following experience and education combinations: 8 years of life sciences manufacturing experience with a high school diploma or GED; 6 years with an associate's degree; 4 years with a bachelor's degree; or equivalent military experience.
Strong troubleshooting ability.
Strong verbal and written communication skills.
Ability to adapt and adjust plans in a fast-paced, changing environment.
Strong time-management skills and critical thinking and problem-solving abilities.
Team-based attitude and ability to work effectively and build relationships in a global team environment.
Ability to work shifts, including weekends and potentially nights.
Ability to work in environments that may require respiratory protection and hearing protection, and to discern audible cues.
Ability to ascend or descend ladders, scaffolding, and ramps; stand and sit for prolonged periods; perform repetitive motions involving wrists, hands, or fingers; move objects up to 33 pounds; bend, push or pull, reach for materials between 18 and 60 inches high, and use twisting motions.
Ability to work at heights greater than 4 feet.

Nice To Haves

Associate's 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 in all unit operations within that 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.
Follow 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 within a functional area.
Ensure work complies with standard operating procedures (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 qualifications for required activities.
Train and mentor junior manufacturing associates.
Support scheduling daily activities on the manufacturing floor and act as supervisor backup as needed.
Lead troubleshooting for operational issues as required.
Assist the supervisor with shift huddles, tier escalations, investigations, and continuous improvement projects as needed.
Lead cycle counts and materials management for the area.
Perform other duties as assigned.