Process Engineer II / Sr. Process Engineer
6701 Kaiser Dr Fremont, CA 94555
The Process Engineer II / Sr. Process Engineer will evaluate, qualify, and implement upstream (cell culture) and downstream (purification) process equipment in the single-use multi-product GMP manufacturing facility (Flextrain). The position will evaluate existing equipment for launch and commercial supply readiness as well as evaluate compliance with data integrity standards. The position will also drive trouble shooting and continuous improvement activities/projects.
The position is responsible for planning and executing projects in a cross-functional project organization in support of New Product Introduction and technology transfer of both internal projects within BI and external projects from clients (Contract Manufacturing Business).
Responsibilities include but are not limited to:
- Evaluate existing equipment for launch and commercial readiness
- Evaluate compliance of equipment with data integrity standards
- Plan process-transfer activities according to timeline and quality
- Plan back-up strategy for process equipment
- Perform technical assessments
- Contribute to NPI and technical risk analysis
- Be point of contact for overall equipment qualification planning and execution
- Provide input on how to maintain and improve plant technology
- Continuous improvement of business and manufacturing processes
- 3+ years’ experience with equipment commissioning, qualification, and validation.
- Knowledge of single-use equipment used in biopharmaceutical GMP production preferred.
- Experience working with computerized systems qualification and validation a plus.
- Good written and oral communication skills. Ability to work in a cross-functional team environment.
- Bachelor’ s Degree in an engineering or biological-related science.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.