Manufacturing Technical Writer - Tech Ops

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 mandatory

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

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