Manufacturing Specialist
Company: FDBT - FUJIFILM Diosynth
Location: Morrisville
Posted on: June 22, 2022
Job Description:
Overview The Manufacturing Specialist is recognized as subject
matter expert with regard to cell culture and/or microbial upstream
and/or recovery and/or downstream manufacturing operations. Ensures
delivery of production execution schedule and adherence to daily
and weekly schedule. Represents Manufacturing at meetings and tours
of manufacturing facility. Initiates and oversees implementation of
operational processes, new technology and modifications to existing
technology or operational processes aimed at cost reduction,
efficiency improvements, minimization of downtime and
quality/safety enhancement. Must be able to identify and
communicate improvement opportunities and results. Provides
feedback regarding operational and manufacturing process
performance. External US The Manufacturing Specialist is recognized
as subject matter expert with regard to cell culture and/or
microbial upstream and/or recovery and/or downstream manufacturing
operations. Ensures delivery of production execution schedule and
adherence to daily and weekly schedule. Represents Manufacturing at
meetings and tours of manufacturing facility. Initiates and
oversees implementation of operational processes, new technology
and modifications to existing technology or operational processes
aimed at cost reduction, efficiency improvements, minimization of
downtime and quality/safety enhancement. Must be able to identify
and communicate improvement opportunities and results. Provides
feedback regarding operational and manufacturing process
performance.MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Assists in readiness by compiling processing checklists and
standard work into binders at the 2 week readiness window for each
batch on the Manufacturing schedule.
- Reviews and updates standard work, as needed
- Creates, reviews, and updates processing checklists, as
needed
- Coordinates equipment calibrations and maintenance
- Supports equipment/instrument qualifications and documentation
with MTS and Validation groups
- Assists in equipment and supplies ordering, as needed
- Primary POC for all Cleaning Validation activities. Works
directly with MTS CV personnel to confirm sampling requirements.
Informs Mfg staff of CV requirements and expectations, plans and
coordinates all CV sampling efforts with MTS, ensures CV samples
are taken and CV documentation is completed RFT
- Performs and owns deviations, CAPA and CC's, as needed, in
support of Cell Culture/ Microbial Manufacturing activities and
improvements.
- Communicates with Mfg staff directly, with use of Tier 1 board
and Shift Plan
- Participates in department and site level OpEx projects
- Interaction with groups such as Materials Management, EHS,
Maintenance, Metrology, MTS, Quality Control and Quality Assurance
(QA)
- Assists in performing Equipment and Room Coordinator tasks, as
needed
- Hosts manufacturing Tours for clients, audits, corporate
visitors
- Represents Manufacturing at technical, planning & scheduling
meetings
- Troubleshooting quality defects and making any process changes
necessary to eliminate the defects; recording corrective and
preventative actions
- Manages Tier 1 and Tier 2 boards
- Delegate for meetings to represent manufacturing when
management unavailable ; including PA's and/ or PPA's
- Ensure and / or Coordinates pick lists, and intermediate thaw
requests with supply chain and warehouse
- Supports interviews of candidates for technician positions, as
needed
- Author, review, and/or revise SOP's, WI's, STD lists, etc. as
needed
- Manages Manufacturing chromatography resin inventory.
Coordinates with SSC for upcoming batches/ campaigns to forecast
and plan resin needs. Plans to utilize Mfg resin inventory first,
before requesting resins from SSC; as applicable
- Reconciles quantity of chromatography resin requested vs used
by Mfg for newly packed columns. Ensures unused, unopened resins
get returned to SDSC / Warehouse and not retained in Mfg inventory.
Ensures that opened, but unused resins get added to Mfg resin
inventory; as applicable
- Completes column packing forms for use in packing columns for
upcoming batches / campaigns; as applicable
- Manages upstream manufacturing Direct Issue requests and Media
inventories as it pertains to manufacturing operations; as
applicable
- All other assigned duties as deemed necessaryORGANIZATIONAL
STRUCTURE: -Position reports to Sr. Production Manager, Associate
Director or Director.WORKING HOURS AND LOCATION: -This is an
on-site position; working-from-home by arrangement. Primarily
Monday-Friday office hours with off- shift hours as necessary or
assigned/needed. This position supports staff working seven days
per week and 24 hours per day. Must be available to consult via
phone, zoom, and in person, when neededBACKGROUND
REQUIREMENTS:Preferred Education, Experience and Skills - Minimum
Requirements:BS/BA (science preferred) and 3+ years of experience
in a cGMP (pharmaceutical/manufacturing environmentOr AA (science
preferred) and 5+ years of experience in a cGMP
(pharmaceutical/manufacturing) environmentPhysical Requirements:
Ability to walk, climb stairs, crawl, kneel and lift, frequently
throughout the shift, up to12 hours.FDBU works with technical data,
technology and materials that are subject to U.S. export laws and
regulations. This position will require access to technical data,
technology and source code that is controlled under U.S. export
laws and regulations, including but not limited to the
International Traffic in Arms Regulations at 22 C.F.R. Parts 120 -
130 and Export Administration Regulations in 15 C.F.R. Part 730 -
774, as may be amended. To conform to these laws and regulations,
applicants must be U.S. citizens, lawful permanent residents of the
U.S., protected individuals as defined by 8 USC 1324(b)(a)(3)
(i.e., asylees and refugees) or otherwise eligible for an export
authorization from the U.S. Department of State or U.S. Department
of Commerce. Offers of employment will be contingent on the
Company's ability to secure an export authorization.FDBU is an
Equal Opportunity Employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, national origin, disability, protected veteran
status, sexual orientation, gender identify or any other protected
class. If an accommodation to the application process is needed,
please e-mail .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.
Keywords: FDBT - FUJIFILM Diosynth, Cary , Manufacturing Specialist, Other , Morrisville, North Carolina
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