Sr Process Engineer 1
Sr Process Engineer 1
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1 Vacancy
Job Description
Position Overview
A Sr Process Engineer 1 provides engineering technical guidance with limited or no direction primarily focusing on client process fit within existing facility designs and specifying equipment and facility gaps for Drug Substance (DS) and Drug Product (DP) processes. This role champions transformation of engineering manufacturing and facility technologies participates in industry forums and provides technical engineering expertise for new processing equipment designs installations and modifications to existing equipment and facility.
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 a technical leader in the client facility fit assessment and process design for equipment facility and operational capabilities
- Manages assessments and feasibility studies for prospective new and expanded capabilities for equipment manufacturing etc.
- Drives engineering studies to confirm process fit to plant for new processes and changes to existing processes
- Provides equipment design expertise and advice to guide major project(s) or other activities
- Leads equipment capital expenditure estimates
- Supports development of procurement packages by partnering with Project Engineering
- Identifies gaps provides suggestions and drives implementation of improvements within the Drug Substance (DS) and Drug Product (DP) manufacturing areas
- Partners with the Process Engineering/Science teams as a lead for identifying process optimizations and potential bottlenecks
- Interacts with senior internal and external personnel on significant matters and crossfunctional coordination as required
- Provides regular updates to senior leadership on strategic initiatives key technical efforts facility fits and investments
- Serves as subject matter expert (SME) for process equipment & technologies including upstream and downstream processes
- Supports site expansion project planning and future design
- Leads transition into technology transfer (detailed mass balance equipment flow diagrams and technical consultation)
- Provides support to Program Management Manufacturing Technical Operations EH&S etc. concerning new client processes and equipment as needed
- Other duties as assigned
Knowledge and Skills
- Knowledge of early phase equipment design and facility layouts
- Knowledge of Drug Substance and/or Drug Product process equipment and unit operations
- Advanced problemsolving skills
- Willingness to partner with global colleagues and lead sub teams
- Effectively present complex information to others
- Ability to lead large meetings including crossfunctional groups and external partners
- Knowledge of Good Manufacturing Practices (GMP) EMEA and Food & Drug Administration (FDA) regulations
- Knowledge of Good Engineering Practices (GEP)
- Effective communication both written and oral
- Ability to adapt communication style to differing audiences and advise on difficult matters
Basic Requirements
- Bachelors degree in Engineering or a related field with 5 years of engineering or other relevant technical experience; or
- Masters degree in Engineering or a related field with 3 years of engineering or other relevant technical experience
- Experience with DS or DP process equipment and unit operations
Preferred Requirements
- Bachelors degree in Engineering or a related field with 8 years of
- Engineering or other relevant technical work experience; or
- Masters degree in Engineering or a related field with 6 years of Engineering or other relevant technical work experience
- Experience with DS or DP process equipment and unit operations
- Prior experience working in a cGMP environment or other highly regulated industry
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. X No Yes
Ability to ascend or descend ladders scaffolding ramps etc. No X Yes
Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes may specify frequency/duration: up to
minutes)
Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes may specify frequency/duration: up to
minutes)
Ability to conduct activities using repetitive motions that include writs hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes 10 lbs. 33 lbs.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. X No Yes
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 .
Required Experience:
Senior IC
Employment Type
Unclear
