Manufacturing -Readiness Coordinator I
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: March 10, 2023
Overview Follow Your Genki to FUJIFILM Diosynth Biotechnologies
(FDB)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.Summary: The Manufacturing Readiness
Coordinator I assist the Manufacturing team to ensure
right-first-time execution on the GMP manufacturing floor and on
time starts by coordinating and delivering readiness milestones.
External US Essential Functions:Responsible for participating in
the following activities within the Manufacturing Support Services
- 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
- Coordinate purchase order creation for client owned/client
- Deliver inputs and outputs necessary for SAP recipe
- Works with Manufacturing and Supply Chain to follow-up on
material ordering and receipt status for GMP manufacturing.
- Generate PO for consumables as applicableDocuments
- 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
- 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
- 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
- Support Potential Problem Analysis (PPA) eventsEquipment and
- Coordinate room/equipment changeover
- Ensure all equipment is in the room prior cleaning and room
- 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
- Review Unicorn methods
- Assist Process Engineers with room layouts
- Induct new/updated equipment into Blue Mountain asset
- 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
- Performs all other duties as assigned.Continuous Learning and
- Participates in team projects relating to Operational
Excellence such as Problem Analysis and PreventionRequired Skills &
- Good oral and written communication skills, interpersonal and
- 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
- Lift up to 25 pounds frequently and up to 50 pounds, on
- Attendance is mandatoryQualifications:
- Bachelor's degree in Biology, Microbiology, Chemistry,
Biochemistry, Engineering or other related field with 1 year of
relevant manufacturing experience in GMP or regulated industry;
- Associate degree / Technical certification in Biology,
Microbiology, Chemistry, Biochemistry, Engineering or other related
field with 2 years of relevant experience, 1 of which should be in
manufacturing, GMP or regulated industry; OR
- High School/GED with 4 years of relevant experience 2 of which
should be in manufacturing, GMP or regulated industryPreferred
- Experience with both Upstream and Downstream cell culture
- Experience with material control and testing requirementsWe 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
e-mail or call .
Keywords: FDBT - FUJIFILM Diosynth, College Station , Manufacturing -Readiness Coordinator I, Professions , College Station, Texas
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