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Manufacturing Readiness Coordinator I

Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: November 14, 2023

Job Description:

Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki.

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Summary : The Manufacturing Readiness Coordinator I assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones.

Responsible for participating in the following activities within the Manufacturing Support Services function:
Work with Supply Chain, Process Development, Manufacturing Operations, Quality Control, and Quality Assurance to identify materials and consumables appropriate for GMP manufacture.
Familiar with preparing material specifications to enable purchasing and release of materials/consumables for use in GMP manufacture.
Coordinate purchase order creation for client owned/client delivered materials
Deliver inputs and outputs necessary for SAP recipe creation
Works with Manufacturing and Supply Chain to follow-up on material ordering and receipt status for GMP manufacturing.
Create standard work for manufacturing readiness, execution, and disposition activities for new customer programs
Generate SOP's and applicable forms for new equipment and route them in document control system
Generate WR for changes / service as needed.
Generate, route and close Change Controls for equipment as required
Familiar with drafting Batch Production Records from Process Specs, update per client review and route for approval
Support Failure Modes and Effects Analysis (FMEA) risk assessments.
Support Potential Problem Analysis (PPA) events
Equipment and Readiness Coordination
Coordinate room/equipment changeover
Ensure all equipment is in the room prior cleaning and room release.
Coordinate with facilities any service or Preventive Maintenance/Corrective Maintenance that needs to be performed to the room or system/equipment in the room.
Identify availability and schedule equipment usage as necessary.
Induct new/updated equipment into Blue Mountain asset management system
Ensure equipment location data is current in Blue Mountain
Generate work requests for changes/service as required
Assist Manufacturing Techs to identify / request / retrieve needs prior to process e.g. Post-use sanitization buffers, AKTA calibration buffers and materials, etc.
Provide PIP support
Originates and tracks manufacturing work orders as necessary.
Participates in team projects relating to Operational Excellence such as Problem Analysis and Prevention

Practical understanding of equipment used in bioprocessing (downstream and/or upstream)
Proficient with Microsoft Office applications.
Must have flexible work hours - must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the manufacturing facilities.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
Master's degree preferably and one (1) year of experience in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; Bachelor's Degree and two (2) year of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; Associate's Degree and four (4) years of experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; High School Diploma or GED and six (6) years' experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations
Experience with material control and testing requirements
We are a company of emboldened goal seekers - driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.
All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. If an accommodation to the application process is needed, please email FDBTHR@fujifilm.Please, no phone calls or emails to any employee of FUJIFILM about this requisition.

Keywords: FUJIFILM Holdings America Corporation, College Station , Manufacturing Readiness Coordinator I, Professions , College Station, Texas

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