Manufacturing Technical Writer - Manufacturing Support
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: March 14, 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 Writer for Manufacturing
Support will be primarily responsible for drafting formulation
records and supporting documents for execution of manufacturing
campaigns to support client needs. Additionally, this role will be
responsible for the creation and revision of Standard Operating
Procedures, Work Instructions/training material and any relevant
technical documentation to support manufacturing activities. This
role requires an understanding of cGMP 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:
- Revise/derive Formulation Records, SOP's, Work Instructions, or
any other technical documentation.
- Ensure that the technical content of all documents is correct,
through collaboration with relevant technical experts.
- Ensure timely execution of deliverables and project timelines
are maintained. Ensuring any exception to the approved timeline is
escalated to relevant stakeholders.
- Work with relevant solution preparation management and the
training department to make sure training material is up to
date
- Work with corrective and preventive action/deviation owners to
assist in any updates or generated documentation according to their
timelines.
- Establish and maintain strong working relationships with
solution prep personnel and external stakeholders.
- 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.
- Works well in an environment with minimal supervision to
accomplish deliverables.
- Ability to work under pressure with changing priorities 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.
- Onsite presence 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 manufacturing environment specifically within buffer
preparations.
- Degree in 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 - Manufacturing Support, Engineering , College Station, Texas
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