Manufacturing Lead Upstream - Nights
FUJIFILM Holdings America Corporation, Raleigh, NC, United States
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, processmonitoringand 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 operation (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 (HR_FDBU@fujifilm.com).
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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, processmonitoringand 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 operation (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 (HR_FDBU@fujifilm.com).
#J-18808-Ljbffr