Engineer Scientist 2 Process Validation
Engineer Scientist 2 Process Validation
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1 Vacancy
Job Description
Position Overview
The Engineer or Scientist 2 for Process Validation helps ensure that manufacturing processes meet the validation and regulatory requirements for the process to be reproducible under normal operating conditions. This role contributes to the design and documentation of process validation protocols for equipment systems and manufacturing processes. Additionally this role works with crossfunctional teams to help ensure processes are consistently producing highquality products in a safe and efficient manner.
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
- Performs process impact assessments root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations as directed
- Supports technology transfer (TT) across multiple unit operations
- Coordinates plans and executes manufacturing process validation runs
- Facilitates generation of sampling plans for process validation reports (PVRs) and investigations
- Writes documentation for internal and external use such as process performance qualification (PPQ) protocol and reports
- Participates in continuous improvement projects in partnership with Manufacturing Quality Engineering and Global teams when applicable to improve manufacturability reliability yield and cost
- Provides support to senior team members in all aspects of process validation as needed
- Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns including onfloor support
- Other duties as assigned
Knowledge and Skills
- Knowledge of Quality Systems (e.g. deviation management system change control CAPA document management system)
- Excellent communication and teamwork skills
- Knowledge of risk management and RCA tools
- Ability to effectively present information to others
- Knowledge of drug substance manufacturing including process validation
- Willingness to provide feedback to others including leaders
- Problemsolving and project management skills
- Knowledge of validation principles and techniques (IQ OQ PQ)
Basic Requirements
- Bachelors degree in Engineering Life Science or Chemical Engineering with 2 years of relevant experience; or
- Masters degree in Engineering Life Science or Chemical Engineering with no prior experience
Preferred Requirements
- Experience working in a Good Manufacturing Practices (GMP) environment
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Ability to ascend or descend ladders scaffolding ramps etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes may specify frequency/duration: up tominutes)
Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes may specify frequency/duration: up tominutes)
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 .
Employment Type
Unclear
