Manufacturing - Readiness Coordinator
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021
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Job Description:
Overview Summary: The Manufacturing Readiness Coordinator
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. External US 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.* Prepare 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.Documents* Create standard work for
manufacturing readiness, execution, and disposition activities for
new customer programs* Author batch records* 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) eventsEquipment and Readiness Coordination*
Coordinate room/equipment changeover* Coordinate room release*
Coordinate schedule for water runs* Review Unicorn methods* 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
PreventionRequired 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 cleanroom 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:* High School Diploma or GED and two (2)
years' experience preferably in biopharmaceutical manufacturing
(GLP or GMP) or supply chain operations; OR* Associate's Degree and
one (1) year of experience.Preferred Qualifications:* Experience
with both Upstream and Downstream cell culture processes*
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 FDBTHR@fujifilm.com or call 979-431-3528.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Manufacturing - Readiness Coordinator, Other , College Station, Texas
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