Manufacturing Lead Downstream - Days

FUJIFILM Holdings America Corporation; North Carolina; On-site; USD 60,000 - 80,000; Full time

Job summary

FUJIFILM Holdings America Corporation is looking for a Manufacturing Lead in North Carolina. This role includes overseeing manufacturing processes, ensuring compliance with CGMP regulations, training junior associates, and contributing to continuous improvement projects. Candidates should have a High School Diploma with 8+ years of CGMP experience or equivalent education. Physical capability to conduct tasks and work in varying environmental conditions is necessary. The position emphasizes a strong focus on safety and operational excellence.

Qualifications

• 8+ years of experience in a CGMP manufacturing environment.
• Experience with multiple unit operations preferred.
• Ability to inspect or perform tasks with corrected vision.

Responsibilities

• Leads and documents manufacturing steps and process monitoring.
• Trains and mentors junior associates.
• Supports troubleshooting for operational issues.

Skills

Safety protocols adherence

Manufacturing process execution

Training and mentoring

Problem-solving

Education

High School Diploma/GED

Associate’s degree in life science

Bachelor’s degree in life science

Job description

Position Overview

The Manufacturing Lead executes and leads manufacturing processing steps, associated activities, and assists the supervisor/manager, as needed. The Lead adheres to and helps ensures all activities performed within the designed shift comply with Current Good Manufacturing Practice (CGMP) and other safety or quality standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

Job Description

Responsibilities:

• Adheres to strict safety protocols and contributes to building a culture of safety within the manufacturing environment
• Leads, executes, and documents manufacturing processing steps or support activities, process monitoring and control within a functional area, ensuring compliance with standard operating procedures (SOPs) and Current Good Manufacturing Practice (CGMP) regulations
• Oversees, leads, or performs in-process sampling and testing (e.g., pH, conductivity, visual inspection)
• Executes validation protocols according to CGMP SOPs and provides approval as a back‑up for the supervisor/manager, as needed
• Trains and mentors junior associates to enhance team capabilities
• Supports scheduling daily activities on the manufacturing floor and serves as a back‑up for the supervisor, as needed
• Leads troubleshooting for operational issues
• Assists the supervisor with shift huddles and tier escalations, investigations, and continuous improvement projects
• Serves as the functional lead for manufacturing execution responsibilities
• Contributes to manufacturing continuous improvement efforts
• Serves as the subject‑matter expert (SME) in at least two core responsibilities for manufacturing‑assigned area
• Maintains training to perform all required activities
• Performs other duties, assigned

Requirements:

• High School Diploma/GED with 8+ years of experience in a CGMP manufacturing environment; or
• Associate’s degree in life science with 6+ years of experience in a CGMP manufacturing environment; or
• Bachelor’s degree in life science with 4+ years of experience in a CGMP environment; or
• Equivalent Military training or experience

Preferred Requirements:

• Experience with multiple unit operations (e.g., Chromatography, UFDF, etc.) and fully qualified in at least one functional area

Physical Demands:

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Will work in environment which may necessitate respiratory protection.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 240 minutes
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 33 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18’ to 60’ in height, and use twisting motions

Environmental Conditions:

• Will work in warm/cold environments (0-100F).

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).