Drug Product Operations - Technician IV
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021
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Job Description:
Overview Summary: The Drug Product Operations Technician IV 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 overseeing 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.* Responsible for
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 all other duties as assigned.Required Skills &
Abilities:* Excellent oral and written communication skills as well
as excellent interpersonal and organizational skills.* Demonstrated
leadership skills.* Ability to train others to perform and maintain
cGMP standards* Strong proficiency with Microsoft Office
applications.* Experience working in cleanroom environments.* 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.* Excellent math and computer skills.* Must
have exceptional 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, and
stretching.* Use hand-eye coordination and manual dexterity
sufficient to operate a keyboard, photocopier, telephone,
calculator, and other office equipment.* Ability to lift up to 25
pounds; frequently, and up to 50 pounds; on occasion.* Attendance
is mandatory.Qualifications:* Master's Degree preferably in
Biology, Microbiology, Chemistry, Biochemistry, Engineering or
related field with 2 years relevant experience of which 1 year must
be in a GMP environment; OR* Bachelor's Degree preferably in
Biology, Microbiology, Chemistry, Biochemistry, Engineering or
related field with 4 years relevant experience of which 1 year must
be in a GMP environment; OR* Associates Degree preferably in
Biology, Microbiology, Chemistry, Biochemistry, Engineering, or
related field with 6 years relevant experience of which 1 year must
be in a GMP environment; OR* High School Diploma with 8 years
relevant experience of which 3 years' must be in a GMP
environment.Preferred Qualifications:* Six Sigma Certification*
Cross training with downstream processes or other identified
functional areas.* Biotechnology Certificate* SAP experience* Train
the Trainer Certification* Drug Product experience* Handling of
Live Virus
Keywords: FDBT - FUJIFILM Diosynth, College Station , Drug Product Operations - Technician IV, Professions , College Station, Texas
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