Manufacturing Lead Upstream

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

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.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: 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) andCurrent Good Manufacturing Practice (CGMP)regulations
Oversees leads or performs in-processsampling andtesting (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 andmentorsjunior associates to enhanceteamcapabilities
Supports scheduling daily activities on the manufacturing floor and serves as a back-up for the supervisor as needed
Leads troubleshooting for operational issues
Assiststhe supervisor with shift huddles and tier escalations investigations and continuous improvement projects
Serves as the functional lead formanufacturingexecution responsibilities
Contributes to manufacturing continuous improvement efforts
Serves as the subject matter expert (SME) inat least twocore responsibilities for manufacturingassigned 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
Associates degree in life science with 6 years of experience in a CGMP manufacturing environment; or
Bachelors 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. Cell Culture Fermentation 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).

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

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EEO Information

Fujifilm is committedto 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 ().

Position OverviewThe 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...