Drug Product Manufacturing Process Engineer I
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: May 14, 2022
The Manufacturing Process Engineer I - is an entry-level
position in the manufacturing department in support of the drug
product life cycle located at the Texas Bio Manufacturing Facility
in College Station, Texas. This position will report directly to
the Sr. Manager DP Manufacturing but may also have a functional
reporting relationship to a senior colleague on a project to
project basis. Works independently, and with colleagues, to provide
expertise and assistance for the design, development,
standardization and maintenance of an operational filler machines
utilized in the aseptic fill for drug product. This person would
become the subject matter expert on core manufacturing and
operational technologies for the manufacturing unit. Operational
biotechnologies include: Isolators and their use in the single use
technology, visual inspection and work under aseptic and clean
rooms. This position will also require to aseptically gown, create
training programs and perform training for manufacturing
technicians in the "shop floor" in the unit operation categories.
External US Essential Functions:Develop and maintain equipment and
unit operation standards and procedures including:
- Develop and deliver effective skill building and training plans
for a given operational technology to manufacturing
- Collaborate with individuals and teams of technicians &
managers on self-development plans.
- Develop and assure alignment of training and skill building
activities to site business requirements.
- Provide guidance and direction on internal and cross-functional
training initiatives. Understand process control and material
inputs to ensure capable and acceptable process output. Guide in
the selection of components materials for drug product in an
aseptic fill. Understand technology operation capabilities, limits
and control strategies.
- Gown and troubleshoot filler machines.
- Receive clients/or service providers and tour area, equipment
- Assist in the selection of new technology for Fill/Finish
(Filler/Isolators, Inspection booth and inspection machines.
- Perform proof of concept by operating the machine.
- Review and/or Approve equipment qualification limits.
- Review Calibration Tolerances and Approve Out of Tolerance
- Represent the manufacturing unit for equipment purchase, new
technology and changes to equipment.
- Lead operational technology standardization, standard batch
templates and instruction interfaces and lead continuous
improvement for a given technology.
- Interface with Process Development and Process Science to
ensure smooth transfer of processes into the manufacturing
- Develop and approve procedures and batch records. Required
Skills & Abilities:
- Excellent oral and written communication skills, interpersonal
and organizational skills.
- Strong leadership skills.
- Ability to gown and train others to perform to cGMP
- Proficient with Microsoft Office applications and statistical ,
OpEx and investigational tools
- 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 the essential functions. While performing
the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, pushing,
pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to
operate a keyboard, photocopier, telephone, calculator, and other
- Lift up to 25 pounds frequently and up to 50 pounds, on
- Attendance is mandatory. Minimum Qualifications:
- Bachelor's degree in Science, Engineering or other related
field and 3 years of relevant experience;
- Associate's degree in Science, Engineering,
Mechanical/Instrumentation or other related field and 4 years of
relevant experience Preferred Qualifications:
- Experience in trouble shooting on Isolators, robotics and/or
- Experience in developing and conducting training
- Experience with laboratory and or manufacturing
- Previous leadership roles.
- GMP experience and regulatory audit experience 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 , Drug Product Manufacturing Process Engineer I, Other , College Station, Texas
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