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.
- 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 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 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 FDBTHR@fujifilm.com or call 979-431-3500.