Position Overview
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.
Company Overview
The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives.
From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.
If you're ready to help transform the future of medicine, join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki.
Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.
Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers
Job Description
Essential Functions:
Responsible for participating in the following activities within the Manufacturing Support Services function:
Materials/Consumables
Familiar with drafting and finalizing process consumables list for new client programs
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.
Generate PO for consumables as applicable
Documents
Create standard work for manufacturing readiness, execution, and disposition activities for new customer programs
Author batch records
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
Review Unicorn Methods and DeltaV recipes with Process Engineer
Review product sample plans
Generate Intermediate and Final product labels and client approval forms as necessary
Review Process Specification
Create tier 2 placards for each new client program.
Review campaign summary report
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 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.
Review Unicorn methods
Assist Process Engineers with room layouts
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.
Performs all other duties as assigned.
Continuous Learning and Improvement
Participates in team projects relating to Operational Excellence such as Problem Analysis and Prevention
Required Skills & Abilities:
Good oral and written communication skills, interpersonal and organizational skills.
Practical understanding of equipment used in bioprocessing (downstream and/or upstream)
Proficient with Microsoft Office applications.
Good self-discipline and attention to detail.
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.
Experience working in clean room environments.
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.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
Attendance is mandatory.
Qualifications:
Master's degree preferably and one (1) year of experience in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; OR
Bachelor's Degree and two (2) year of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; OR
Associate's Degree and four (4) years of experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; OR
High School Diploma or GED and six (6) years' experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations
All above requirements must include at least one (1) year of GLP or GMP experience
Preferred Qualifications:
Experience with both Upstream and Downstream cell culture processes
Experience with material control and testing requirements
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 (FDBTHR@fujifilm.com or (979) 431-3500).
Job Locations US-TX-College Station
Posted Date 1 day ago (6/11/2025 12:51 PM)
Requisition ID 2025-34836
Category Manufacturing
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies
