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Drug Product Process Engineer

Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 15, 2022

Job Description:

The Drug Product Process Engineer is a mid-level position in the Drug Product Operations department in
support of the production of drug product in the Texas BioManufacturing Facility - 100 (TBF-100) and the Flexible
BioManufacturing Facility - 200 (FBF-200) in College Station, Texas. Drug Product Operations utilizes a state of the art
Aseptic Filling Workcell to provide scalable, flexible capacity for sterile injectable manufacturing. As a CDMO, customer
liaison is a vital part of our business and the Drug Product Technical Operations team will act as the point of contact for
our customers during manufacturing execution.
The individual in this position will work independently and with colleagues to provide expertise and assistance for the
design, development, standardization and maintenance of the technology utilized in the manufacture of drug product.
This person would become the subject matter expert on core manufacturing and operational technologies for the drug
product manufacturing unit. Operational technologies include: Isolators in the preparation of components required for
aseptic filling and gloveless robotic isolator technology in the aseptic filling of drug product.

External US
Essential Functions:
--- Responsible for specifying, purchasing, designing, qualifying, and handing over effective manufacturing systems
ensuring plant modifications have credible delivery plans.
--- Responsible for interfacing with internal / external technical experts and peers to maintain a broad knowledge of
the technology and regulatory issues that impact the biopharmaceutical business enabling technology options to
be identified, evaluated and compared.
--- Assist in the creation / transfer of new processes and technologies to the manufacturing plant ensuring
requirements for EHS and cGMP compliance.
--- Manage the interface between Process Development and Manufacturing to ensure processes and transfers occur
seamlessly and provide process engineering expertise to siting exercises placing new processes into the facility.
--- Help in identifying improvement to an managing change of technology transfer practices to deliver continuous
--- Assist in the training and coaching of project team members to ensure technical and personal objectives are
achieved within agreed time frames.
--- Ensure best practice operating methods are deployed and assist in resolving operational problems such as
deviations, QIPs, CAPAs, etc.
--- Take the lead in investigating and resolving events that arise from compliance issues.
--- Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials,
Machinery and Methods) approach.
--- All other duties as may be assigned.
Required Skills & Abilities:
--- Excellent oral and written communication skills, interpersonal and organizational skills.
--- Strong leadership skills.
--- Ability to train others to perform to cGMP standards.
--- Proficient with Microsoft Office applications.
--- Good self-discipline and attention to detail; ability to work under minimal supervision.
--- Must have flexible work hours - must be willing to work outside of normally scheduled hours as necessary;
including opportunities for alternative shift hours and weekends as required.
--- Experience working in cleanroom environments under sterile or aseptic conditions; must have experience in
engineering standards required for this type of operation.
--- Must have good planning skills and must be willing to interface with and guide colleagues in many different roles
and functions throughout the manufacturing facilities.
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 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
--- Use hand-eye coordination and manual dexterity sufficient to operate in a laboratory and/or manufacturing
--- Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion.
--- Attendance is mandatory.

--- Master's degree preferably in Science, Engineering, or other related field and with three (3) years' of relevant
experience; OR
--- Bachelor's degree preferably in Science, Engineering, or other related field and with five (5) years' of relevant
--- Above experience must include one (1) year GMP experience.

Preferred Qualifications:
--- Experience developing training materials
--- Experience conducting and evaluating training
--- Experience with laboratory and or manufacturing instruments/equipment
--- Previous leadership roles

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 or call 979-431-3528.

Keywords: FDBT - FUJIFILM Diosynth, College Station , Drug Product Process Engineer, Engineering , College Station, Texas

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