Process Engineer 3 - Cell Culture FATs
Process Engineer 3 - Cell Culture FATs
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Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
This position reports to the Process Engineering Manager Upstream in support of the Process Equipment team for the Galaxy project a greenfield construction project in Holly Springs NC. The initial assignment is to assume the Responsible Engineer role for the Seed Train unit operations.
As the site moves into commercial operations circa 2025 this position is planned to continue as a Process Engineering role supporting commercial operations technology transfers and small capital projects related to the same unit operation. Additional details regarding job responsibilities are below.
Company Overview
Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture 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 we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a newlargescale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest endtoend cell culture CDMO provider in North America.
The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.
Job Description
What Youll Do
Serves as point of contact to the Engineering Procurement Construction Management (EPC) provider
Secures on time delivery and ensures quality from Fujifilm and EPCM provider for moderate complexity equipment packages
Develops and aligns moderate complexity plans and provides mitigations as needed
Reviews piping and instrumentation diagram (P&IDs) and other process design documents
Provides direction to detailed design activities in partnership with the EPCM provider
Writes User Requirement Specifications (URSs)
Supports Factory Acceptance Testing (FAT) Commissioning Qualification and Validation (CQV) and startup activities
Serves as oncall support for process equipment
Reviews redlines and approves P&IDs and other technical documents as the technical authority
Leads system impact assessments and quality risk assessments for process equipment
Performs technology transfer (TT) activities related to process equipment
Supports of Good Manufacturing Practices (GMP) runs
Provides technical support for root cause analysis (RCA) and process deviation investigations
Leads or assists with deviations change controls and corrective and preventive action (CAPA) closures
Makes decisions regarding technical risk assessments for new manufacturing equipment
Provides onfloor manufacturing support for equipment issues
Provides process equipment training and consultation on topics within assigned area(s)
Participates in identifying continuous improvement projects within unit operations in partnership with Manufacturing when applicable to improve
manufacturability reliability yield and cost
Supports supplier technical evaluations risk assessments and equipment evaluation and qualification
Conducts training and presents information to team or other stakeholders
Crosstrains on unit operations to assist team with achieving deliverables
Collaborates with other departments such as Quality Manufacturing Process Science Maintenance and Automation
Other duties as assigned
Minimum Requirements
Bachelors degree in Chemical or Biotechnology Engineering or another related field with 5 years of Engineering or other relevant technical experience; or
Masters in Chemical or Biotechnology Engineering with 3 years of Engineering or other relevant technical experience
Experience in Life Science or other regulated industry
Experience with Engineering drawings and Quality Systems (e.g.deviation management change control CAPA document
management system)
Preferred Requirements
Prior experience working in a cGMP environment or other highly regulated industry
Experience working in harvest unit operations (Centrifugation Filtration) in a pharmaceutical or Life Science environment
Experience with mammalian cell culture processes
Working & Physical Conditions
Ability to ascend or descend ladders scaffolding ramps etc.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 240 minutes.
Ability to conduct activities using repetitive motions that include wrists hands or fingers.
Ability to operate machinery and/or power tools.
Ability to conduct work that includes moving objects up to 33 pounds.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and using twisting motions.
Will work in warm/cold environments.
Will work in small and/or enclosed spaces.
Will work in heights greater than 4 feet.
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 viaemail 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.
EEO Information
Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .
Employment Type
Unclear
