Manufacturing Technical Writer - Tech Ops
- FUJIFILM Diosynth Biotechnologies
- College Station, TX
- Start date
- Mar 6, 2023
- Clinical, Clinical Documentation, Information Technology, Applications/Technical Support
- Required Education
- High School or equivalent
- Position Type
- Full time
- Lone Star Bio
- 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 mandatory
- 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.
- 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 FDBTHR@fujifilm.com or call 979-431-3500.
FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.
With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.
Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.
Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.Create alert