Manufacturing Support Associate 2, Drug Product

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

The Manufacturing Support Associate 2 provides reliable support to the Drug Product Manufacturing operation during the establishment of the facility and processes. This position supports the creation of standard operating procedures processes trainings and documentation along with supporting tech transfer batch planning documentation updates and coordination of nonbatch activities including changeover PMs deviation management and audit preparation.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

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

What Youll Do

During the project phase support operational readiness initiatives as well as site commissioning and qualification
Owns and drives drug product operational readiness document plan contribute to preparation of standard operating processes (SOPs) and documentation packages as defined by the project plan
Participates in operational readiness project meetings and support factory acceptance testing (FAT) and site acceptance testing (SAT) as required
Actively participates in establishment of batch handling processes for Drug product manufacturing
Executes and drives minor projects and initiate change management request including optimization projects
Leads and guides shop floor deviation investigation from initiation through closure
Provides training and mentor junior level team members
Perform other duties as assigned

Basic Requirements

High School Diploma or GED with 6 years direct experience OR
Associates degree with 4 years of direct experience OR
Bachelors degree with 2 years of direct experience OR
Equivalent Military training or experience

Preferred Requirements

Associate degree in life sciences
BA/BS in life sciences or engineeringPrior cGMP experience from a pharmaceutical production environment
Preferable operational experience with formulation filling and visual inspection processes and production equipment
BioWorks or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
Ability to discern audible cues.
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color.
Ability to ascend or descend ladders scaffolding ramps etc.
Ability to stand for prolonged periods of time.
Ability to sit for prolonged periods of time.
Ability to conduct activities using repetitive motions that include writs hands and/or fingers.
Ability to operate machinery and/or power tools.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions

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.

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 ().

Required Experience:

Position OverviewThe Manufacturing Support Associate 2 provides reliable support to the Drug Product Manufacturing operation during the establishment of the facility and processes. This position supports the creation of standard operating procedures processes trainings and documentation along with s...