Process Sciences- Sr. Engineer
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021
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Job Description:
Overview Summary: The Senior Engineer functions independently
and productively within a team based organization to actively
address complex cGMP manufacturing issues. The individual is
responsible for analyzing process technologies in support of new
project proposals and takes responsibility for the technical
transfer into the manufacturing group. This individual must work in
a collaborative manner coordinating the transfer of biological drug
processes from process development (internal or client) groups in a
CMO environment.External US Essential Functions: * Applies
scientific and cGMP manufacturing expertise to research and resolve
issues in the technology transfer and implementation of client
specified manufacturing processes for biologics including viral
based products and vaccines.* Leads multiple overlapping
cross-functional technology transfer teams that include client
technical staff and internal process development and manufacturing
teams. Will also be responsible for assisting other teams as SME.*
Research and recommend single-use process equipment of appropriate
scale and quality for the cGMP execution of client specified
manufacturing processes.* Responsible for the preparation of user
requirements, vendor quotes, and purchasing of equipment as well as
supporting capital projects by providing technical expertise.*
Oversees and leads small complex engineering projects.* Assist in
overseeing contractor activities, as required.* Provides technical
information for the preparation of change controls, protocols, and
new user training for the process equipment.* Reviews process
requirements for GMP manufacturing through process specifications
and batch records.* Identifies raw materials and consumables of
appropriate quality for the cGMP execution of client specified
manufacturing processes; assists in the preparation of material
specifications, vendor quotes, and the purchase of the materials.*
Responds to client and/or internal staff questions or concerns
about cGMP equipment, materials, and procedures.* Uses key and
critical process parameters and their associated critical quality
attributes to assist in the preparation of product specifications.*
Provides data analysis from each manufacturing run that will be
included in intermediate and final project summary reports and
other team deliverables.* Contributes to and ensures the
achievement of goals and tech transfer milestones on multiple
projects without delay in schedule or excessive use of resources.*
Perform all other duties as assigned.Required Knowledge/Technical
Expertise Individual will have knowledge/expertise relevant to:*
supporting single-use equipment and systems such as:* Fermentation
and Cell Culture reactors* GE AKTA chromatography systems supported
by Unicorn software* Tangential Flow Filtration Systems* Depth
Filtration systems* Working within cGMP environments in relation to
biologics and vaccine manufacturing.* Process development or
manufacturing experience with clinical scale projects.* Single-use
manufacturing equipment and materials.* Understanding and
experience in aseptic techniques.* Document writing including
protocols, batch records, and SOPs and summary reports.* Using
Microsoft Excel, Word, and PowerPoint.Other Abilities:*
Demonstrated credibility by performing high quality work.* Coaching
and mentoring less experienced team members.* Expand the technical
capabilities of teams using academic and hands-on experience.*
Effectively communicates results of own work through meetings,
presentations, discussions and documentation with some input from
supervisor.* Minimum supervision required on day-to-day activities
and accomplished tasks.* Ability to work in a team oriented
environment is essential, as this person will work closely with
other team members and clients.* Self-motivated and capable of
demonstrating technical competence. * Excellent interpersonal
communication skills and ability to influence and collaborate in a
team environment.* Analytical and excellent problem-solving
skills.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 standing, along with 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 20 pounds regularly and up to 50 pounds on occasion.*
Potential for exposure to hazardous chemicals, gases, fumes, odors,
mists, and dusts, and other hazardous materials.* Ability to wear
personal protective equipment to include safety glasses, lab coat,
gloves or other equipment as required.* Attendance is
mandatory.Minimum Qualifications:* PhD with 1 year of relevant
experience; OR* Master's Degree with 6 years of relevant
experience; OR* Bachelor's Degree with 8 years of relevant
experience; OR* Associate's Degree with 10 years of relevant
experience.Preferred Qualifications:* Experience in a GMP
environment.* Degree in Engineering, Chemistry, Biology, Life
Sciences or related field.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 979-431-3528.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Process Sciences- Sr. Engineer, Other , College Station, Texas
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