Process Sciences- Sr. Engineer
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: May 14, 2022
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
- 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
- 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
- Tangential Flow Filtration Systems
- Depth Filtration systems
- Working within cGMP environments in relation to biologics and
- Process development or manufacturing experience with clinical
- 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
- Effectively communicates results of own work through meetings,
presentations, discussions and documentation with some input from
- Minimum supervision required on day-to-day activities and
- Ability to work in a team oriented environment is essential, as
this person will work closely with other team members and
- Self-motivated and capable of demonstrating technical
- 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
- Ability to lift up to 20 pounds regularly and up to 50 pounds
- 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 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 email or call .
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Process Sciences- Sr. Engineer, Engineering , College Station, Texas
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