Process Sciences- Engineer II
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 13, 2022
Overview Summary: - The Engineer II functions 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 assist in 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
- Applies scientific and cGMP manufacturing expertise to address
issues in the technology transfer and implementation of client
specified manufacturing processes for biologics including viral
based products and vaccines.
- Lead multiple overlapping cross-functional technology transfer
teams that include client technical staff and internal process
development and manufacturing teams.
- Identification of single-use process equipment of appropriate
scale and quality for the cGMP execution of client specified
- Prepares user requirements, obtains vendor quotes, and Capital
Requests for equipment.
- Provides technical information for the preparation of change
controls, protocols, and new user training for the process
- Reviews process specifications and provides input for scale up
and requirements for GMP manufacturing.
- Reviews batch records prepared based on the process
- 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 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 ExpertiseIndividual will have
knowledge/expertise relevant to:
- Working within cGMP environments in relation to biologics and
- Hands on process development or manufacturing experience with
clinical scale projects.
- Experience with single-use manufacturing equipment and
- Documented understanding and experience in aseptic
- Document writing including protocols, batch records, and SOPs
and summary reports.
- Experience with Microsoft Excel, Word, and PowerPoint and
materials management with SAP.Other Abilities:
- Build credibility by performing high quality work.
- Expand the technical capabilities of teams using academic and
- Trains other members of the team with respect to the day-to-day
goals and activities by imparting their expertise to the
- 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; OR
- Master's Degree with 4 years of relevant experience; OR
- Bachelor's Degree with 6 years of relevant experience; OR
- Associate's Degree with 8 years of relevant
- Experience in a cGMP environment.
- Degree preferably 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 FDBTHR@fujifilm.com
or call 979-431-3528. -
Keywords: FDBT - FUJIFILM Diosynth, College Station , Process Sciences- Engineer II, Engineering , College Station, Texas
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