Process Sciences - Engineer I
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: May 4, 2021
Overview Summary: The Engineer I 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 Functions:
- Assists in applying 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.
- Serves on cross-functional technology transfer teams that
include client technical staff and internal process development and
- Assists in the identification of single-use process equipment
of appropriate scale and quality for the cGMP execution of client
specified manufacturing processes.
- Assists in the preparation of user requirements, vendor quotes,
and purchasing of equipment.
- 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 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
- Understanding and experience in aseptic techniques.
- Document writing including protocols, batch records, and SOPs
and summary reports.
- Experience with Microsoft Excel, Word, and PowerPoint.Other
- Build credibility by performing high quality work.
- Expand the technical capabilities of teams using academic and
- May be required to train other members of the team with respect
to the day-to-day goals and activities by imparting their expertise
to the group.
- 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
- Good interpersonal communication skills and ability to
influence and collaborate in a team environment.
- Analytical and 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
- Attendance is mandatory.Minimum Qualifications:
- Master's Degree preferably in Chemistry, Biology, Life Sciences
or related field, with 2 years' of relevant experience preferably
in a cGMP environment; OR
- Bachelor's Degree preferably in Chemistry, Biology, Life
Sciences or related field, with 4 years' of relevant experience
preferably in a cGMP environment; OR
- Associate's Degree preferably in Chemistry, Biology, Life
Sciences or related field, with 6 years' of relevant experience
preferably in a cGMP environment; OR
- High School degree with 10 years' of relevant experience
preferably in a cGMP environment.Preferred Qualifications:
- Experience in pharmaceutical or biotechnology industry.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Process Sciences - Engineer I, Other , College Station, Texas
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