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Drug Product Operations Technician

Employer
FUJIFILM Diosynth Biotechnologies
Location
College Station, TX
Start date
Nov 29, 2022

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Job Details

  The Drug Product Operations Technician I will work directly with the Vanrx SA25 Vial Filling Isolator,. following aseptic techniques and procedures in a cGMP environment. 

External US

Essential Functions

  • Responsible for the operation of Vanrx SA25 Vial Filling Isolator.
  • Responsible for assisting in the formulation of the bulk drug product in accordance to procedures.
  • Responsible for visual inspection and labeling of filled bulk drug product vials in accordance to procedures.
  • Assist in writing, reviewing, and/or updating Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).
  • Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
  • Help implement project safety and quality assurance programs in collaboration with senior staff and EH&S.
  • Ensure proper documentation and execution of Batch Production Records for assigned projects.
  • Maintain confidentiality of proprietary company information.
  • Participate in incident investigations.
  • Maintain an effective working relationship with others.
  • Perform daily cleaning and sanitization on the laboratory.
  • Perform all other duties as assigned.

 

Required Skills & Abilities

  • Good oral and written communication skills as well as excellent interpersonal and organizational skills.
  • Strong proficiency with Microsoft Office applications.
  • Must have flexible work hours, and be willing to work outside of normal, scheduled hours, as necessary. Must be able to work alternative shift hours and weekends as required.
  • Self-discipline and good attention to detail.
  • Good math and computer skills.
  • Must possess good planning skills and be willing to interface with colleagues in many different roles and functions throughout the manufacturing facilities and lead projects.
  • Gowning

 

Working Conditions & Physical Requirements

The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.  While performing the duties of this job, the employee is required on a regular basis to

  • Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate in a laboratory and/or manufacturing environment.
  • Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion.
  • Attendance is mandatory.

 

Qualifications

  • Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field;  OR
  • High School Diploma/GED with 1 year of work experience.

 

Preferred Qualifications

  • Experience in a GMP environment
  • Biotechnology Certificate

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 email FDBTHR@fujifilm.com or call 979-431-3528.

 

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Company

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.

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Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
US
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