Manufacturing Technician III-Drug Product Operations - Fujifilm

Overview

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. 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Summary:  The Manufacturing Technician III-Drug Product Operations 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.

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.

Minimum Qualifications:

• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field with one (1) year of relevant manufacturing experience in GMP or regulated industry; OR
• Associate degree / Technical certification in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field with two (2) years of relevant experience, one (1) of which should be in manufacturing, GMP or regulated industry; OR
• High School/GED with four (4) years of relevant experience, two (2) of which should be in manufacturing, GMP or regulated industry.

Preferred Qualifications:

• Experience in a GMP environment
• Biotechnology Certificate

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.

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 979-431-3500.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.