SENIOR MANUFACTURING PROCESS ENGINEER
Company: FUJIFILM Corporation
Location: College Station
Posted on: September 30, 2024
Job Description:
OverviewThe work we do at FDB has never been more important-and
we are looking for talented candidates to join us. We are growing
our locations, our capabilities, and our teams, and looking for
passionate, mission-driven people like you who want to make a real
difference in people's lives. Join FDB and help create the next
vaccine, cure, or gene therapy in partnership with some of the most
innovative biopharma companies across the globe. We are proud to
cultivate a culture that will fuel your passion, energy, and drive
- what FDB call Genki. -College Station, Texas may be a small,
university town, but the lively cultural scene and local amenities
make it a great place for families as well as those who want the
ease of small-town life and the convenience of living close to the
vibrant pulse of big cities. Eighty-seven percent of Texas'
population lives within a 180-mile radius, so we are in the center
of it all in Texas. And our site is nestled in the hub of
innovation, representing a source of pride for the area.Summary:
-The Sr. Manufacturing Process Engineer works independently, with
minimal supervision, and leads projects and colleagues to provide
expertise and assistance for the design, development,
standardization and maintenance of operational biotechnology
utilized in the manufacture of proteins and drug substances. This
person will be the subject matter expert on core manufacturing and
operational technologies for the manufacturing unit. Operational
biotechnologies include: Isolators and their use in cell
propagation, Cell Culture/Single Use Technology, Filtration,
Chromatography and Final Filtration. Core manufacturing
technologies include Weigh and Dispensing and Mixing and Buffer
Preparation.External USEssential Functions:
- Responsible for specifying, purchasing, designing, qualifying,
and handing over effective manufacturing systems ensuring plant
modifications have credible delivery plans.
- Lead continuous improvement of materials to reduce risk and
improve efficiencies.
- Responsible for interfacing with internal / external technical
experts and peers to maintain a broad knowledge of the technology
and regulatory issues that impact the biopharmaceutical business
enabling technology options to be identified, evaluated, and
compared.
- Lead transfer and scale up of new processes and technologies to
the manufacturing plant ensuring requirements for EHS and cGMP
compliance.
- Manage the interface between Process Development and
Manufacturing to ensure processes and transfers occur seamlessly
and provide process engineering expertise to siting exercises
placing new processes into the facility.
- Identify and lead change of technology transfer practices to
deliver continuous improvements.
- Lead in the training and coaching of project team members to
ensure technical and personal objectives are achieved within agreed
time frames.
- Ensure best practice operating methods are deployed and assist
in resolving operational problems such as deviations, QIPs, CAPAs,
etc.
- Take the lead in investigating and resolving events that arise
from compliance issues.
- Develop and maintain equipment and unit operation standards and
procedures utilizing 4M (Man, Materials, Machinery and Methods)
approach.
- All other duties as may be assigned.Required Skills &
Abilities:
- Excellent oral and written communication skills, interpersonal
and organizational skills.
- Excellent leadership skills.
- Ability to train others to perform to cGMP standards.
- Proficient with Microsoft Office applications.
- Good self-discipline and attention to detail.
- 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.
- Excellent math and computer skills.
- Experience working in cleanroom environments.
- 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
office equipment.
- Lift up to 25 pounds frequently and up to 50 pounds, on
occasion.
- Attendance is mandatory.Minimum Qualifications:
- Bachelor's degree preferably in Science, Engineering, or other
related field and with four (4) years of relevant experience;
OR
- Associate's degree preferably in Science, Engineering or other
related field and six (6) years of relevant experience; OR
- High School/GED with eight (8) years of relevant
experience.
- Above experience must include four (4) years GMP
experience.Preferred Qualifications:
- Experience in developing training materials.
- Experience conducting and evaluating training.
- Experience with laboratory and or manufacturing
instruments/equipment.
- Previous leadership roles.Join us! - FDB is advancing
tomorrow's medicine, impassioning employees to chase the impossible
and continually expand their potential. - We are a company of
emboldened goal seekers - driven by an innate desire to better
ourselves, our families, our workplace, our company, our community,
and the world at large.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 979-431-3500.To all agencies: Please, no phone calls or emails
to any employee of FUJIFILM about this requisition. All resumes
submitted by search firms/employment agencies to any employee at
FUJIFILM via-email, the internet or in any form and/or method will
be deemed the sole property of FUJIFILM, unless such search
firms/employment agencies were engaged by FUJIFILM for this
requisition and a valid agreement with FUJIFILM is in place. In the
event a candidate who was submitted outside of the FUJIFILM agency
engagement process is hired, no fee or payment of any kind will be
paid.
Keywords: FUJIFILM Corporation, College Station , SENIOR MANUFACTURING PROCESS ENGINEER, Engineering , College Station, Texas
Didn't find what you're looking for? Search again!
Loading more jobs...