Manufacturing Technical Writer - Tech Ops
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: March 15, 2023
Job Description:
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 Technical Operations - Technical
Writer will be responsible for drafting batch records for execution
of manufacturing campaigns to support client needs. Additionally,
this role will be responsible for the creation and revision of
PCL's, procedures and protocols to support manufacturing
activities. This role requires an understanding of GMP production,
a strong proficiency in Microsoft Office functions, as well as an
active approach to learning the latest best practices across the
business. External US Essential Functions:
- Generate and drive to completion Batch Production Records,
Formulation Records, PCL's, SOP's and WI's.
- Ensure that the technical content of all documents is correct
and approved by relevant technical lead.
- Ensure Technical lead and program management is appropriately
updated with progress of document generation and identify conflicts
for timely completion.
- Support internal regulatory data requests.
- Escalate to Technical Operations Manager and Program
Management, as applicable, if there will be a delay to generation
of documents.
- All other duties as assigned. Required Skills & Abilities:
- Excellent IT Skills using Microsoft or similar software.
- Knowledge of Trackwise and Master Control or similar
software.
- Excellent interpersonal skills.
- Ability to interpret, organize and present complex information
in a clear and concise manner.
- Ability to work against fixed timelines. 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 sitting, standing, walking, bending,
stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to
operate a keyboard, photocopier, telephone, calculator, and other
office equipment is required.
- Attendance is mandatoryMinimum Qualifications:
- Bachelor's degree in Biology, Microbiology, Chemistry,
Biochemistry, Engineering, or related field with 2 years'
experience in a manufacturing environment.
- Associate degree in Biology, Microbiology, Chemistry,
Biochemistry, Engineering, or other related field and 4 years'
experience in a manufacturing environment.
- High School/GED and 6 years in a manufacturing
environment.
- Above requirements must include 1 year of GMP
experience.Preferred Qualifications:
- Relevant technical writing experience in a biotechnology or
pharmaceutical development and manufacturing environment of medium
to high complexity.
- Degree in Business, Engineering, Microbiology, Chemistry,
Biochemistry, or related field.
- Experience in a cGMP facility.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 e-mail or call .
Keywords: FDBT - FUJIFILM Diosynth, College Station , Manufacturing Technical Writer - Tech Ops, Engineering , College Station, Texas
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