CGMP Manufacturing Lead – 24/7 Operations & Process Expert

FUJIFILM Healthcare Americas Corporation; Milwaukee (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a Manufacturing Lead to drive manufacturing steps, enforce CGMP standards, and assist the supervisor. The role requires leading processes, performing in-process sampling, and mentoring junior staff in a 24/7 production setting.

The ideal candidate has a strong life-science background with 4+ years in CGMP manufacturing, plus hands-on experience with unit operations and safety procedures.

Qualifications

• Experience in CGMP manufacturing environments is required.
• Ability to execute, document, and validate manufacturing steps per SOPs and CGMP.
• Experience training and mentoring junior associates.

Responsibilities

• Adheres to safety protocols and promotes a culture of safety in manufacturing.
• Leads, executes, and documents manufacturing steps; monitors processes and controls SOPs/CGMP.
• Oversees in-process sampling and testing (pH, conductivity, visual inspection).
• Executes validation protocols and backs up supervisor/manager when needed.
• Trains and mentors junior staff; supports daily manufacturing scheduling.
• Leads troubleshooting and drives continuous improvement projects.
• Serves as functional lead for manufacturing execution and SME in two core areas.

Skills

Safety protocols

CGMP compliance

SOP adherence

Lead and back-up supervision

Process monitoring

In-process sampling

Mentoring juniors

Shift coordination

Continuous improvement

Education

High School Diploma/GED

Associate's degree in life science

Bachelor's degree in life science

Equivalent Military training or experience

Job description

FUJIFILM Biotechnologies is seeking a Manufacturing Lead to drive manufacturing steps, enforce CGMP standards, and assist the supervisor. The role requires leading processes, performing in-process sampling, and mentoring junior staff in a 24/7 production setting.

The ideal candidate has a strong life-science background with 4+ years in CGMP manufacturing, plus hands-on experience with unit operations and safety procedures.