Manufacturing Readiness Coordinator II - Fujifilm

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. 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. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Summary:  The Manufacturing Readiness Coordinator II 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. 

Essential Functions:

Responsible for participating in the following activities within the Manufacturing Support Services function:

Materials/Consumables

• Draft and finalize  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 and two (2) years of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; OR
• Bachelor’s Degree and four (4) years of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; OR
• Associate degree and six (6) years of experience, preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; OR 
• High School Diploma or GED and eight (8) years’ experience in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations
• All above requirements must include at least two (2) years’ of GLP or GMP experience

Preferred Qualifications:

• Experience with both Upstream and Downstream cell culture processes
• Experience with material control and testing requirements

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  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.

We are an equal opportunity and affirmative action employer.  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.com or call 979-431-3500.

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 place. 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.