Bioprocess Engineer
Job Description
Responsibilities:
Generates manufacturing plan based on the product requirements and the anticipated manufacturing resources needed to produce and ship the new product.
Prepares and submits SOP's, WI's, BOM's, routings and standard costing for new product into SAP Involved in providing floor support Independently performing root cause analysis for product complaints through experiments involving flow cytometry/applications and production process evaluations including physical property or analytical data analysis.
Responsible for the timely documentation of the results and conclusions.
Evaluates failures, writes Variance Reports (VR's), presents recommendations to Material Review Board Analyzes and solves complex and challenging problems in Production and Quality Control.
Provides support by providing flow cytometry expertise to experimental strategy, problem characterization, data acquisition and analysis.
Evaluates product history, recommends revisions to product specifications, originates Change Orders (CO's) Extensive knowledge in product lines or manufacturing processes.
Identifies areas for improvements in product quality, process capability and production costs.
Applies Lean and Six Sigma practices into the development, scale up and setup of the manufacturing processes.
Design, writing and execution of Gage R&R, scale up, stability, and validation studies.
Design, Write and Implement all development activities and reports, validation protocols for manufacturing E&P.
Ensures validation of equipment and processes, evaluates data and writes reports, with minimal support.
Interfaces with Product Development, Research, Quality, Regulatory and Production to bring new technologies, methods, and tests into Manufacturing.
Evaluates technologies and processes for reliability, production capability, consistency, and cost effectiveness.
Makes recommendations for process improvements.
Assists and mentors fellow associates to develop skills and techniques.
Trains Chemists/Technicians in processes and procedures.
Keeps abreast of the basic requirements for compliance of their work.
Participates as required in training on regulatory issues affecting own area of work.
Brings regulatory compliance questions/issues to the attention of management.
Promotes a safe work environment.
May provide recommendations on maintaining the safety of the work environment.
Participates in Environmental Health and Safety programs.
Addresses corrective actions whenever a hazard is identified.
Notifies supervisor of all observed hazardous conditions or unsafe work practices Requirements:
Requires a Bachelor degree with 7 years of experience; Or a Master's degree with 5 years of experience; Or PhD with 2 years of Industry experience in biological sciences or related field.
6 years of experience in FDA or ISO regulated production environment.
At least a one year of experience in managing a large or complex project.
Experience in statistical analysis, Six Sigma.
Technical expertise in molecular biology/antibody techniques, instrumentation, and assays performed Project management experience Experience in SAP/ related Enterprise management system.
Recommended Skills Antibodies Biochemical Assays Biology Business Process Improvement Data Analysis Data Collection Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Generates manufacturing plan based on the product requirements and the anticipated manufacturing resources needed to produce and ship the new product.
Prepares and submits SOP's, WI's, BOM's, routings and standard costing for new product into SAP Involved in providing floor support Independently performing root cause analysis for product complaints through experiments involving flow cytometry/applications and production process evaluations including physical property or analytical data analysis.
Responsible for the timely documentation of the results and conclusions.
Evaluates failures, writes Variance Reports (VR's), presents recommendations to Material Review Board Analyzes and solves complex and challenging problems in Production and Quality Control.
Provides support by providing flow cytometry expertise to experimental strategy, problem characterization, data acquisition and analysis.
Evaluates product history, recommends revisions to product specifications, originates Change Orders (CO's) Extensive knowledge in product lines or manufacturing processes.
Identifies areas for improvements in product quality, process capability and production costs.
Applies Lean and Six Sigma practices into the development, scale up and setup of the manufacturing processes.
Design, writing and execution of Gage R&R, scale up, stability, and validation studies.
Design, Write and Implement all development activities and reports, validation protocols for manufacturing E&P.
Ensures validation of equipment and processes, evaluates data and writes reports, with minimal support.
Interfaces with Product Development, Research, Quality, Regulatory and Production to bring new technologies, methods, and tests into Manufacturing.
Evaluates technologies and processes for reliability, production capability, consistency, and cost effectiveness.
Makes recommendations for process improvements.
Assists and mentors fellow associates to develop skills and techniques.
Trains Chemists/Technicians in processes and procedures.
Keeps abreast of the basic requirements for compliance of their work.
Participates as required in training on regulatory issues affecting own area of work.
Brings regulatory compliance questions/issues to the attention of management.
Promotes a safe work environment.
May provide recommendations on maintaining the safety of the work environment.
Participates in Environmental Health and Safety programs.
Addresses corrective actions whenever a hazard is identified.
Notifies supervisor of all observed hazardous conditions or unsafe work practices Requirements:
Requires a Bachelor degree with 7 years of experience; Or a Master's degree with 5 years of experience; Or PhD with 2 years of Industry experience in biological sciences or related field.
6 years of experience in FDA or ISO regulated production environment.
At least a one year of experience in managing a large or complex project.
Experience in statistical analysis, Six Sigma.
Technical expertise in molecular biology/antibody techniques, instrumentation, and assays performed Project management experience Experience in SAP/ related Enterprise management system.
Recommended Skills Antibodies Biochemical Assays Biology Business Process Improvement Data Analysis Data Collection Estimated Salary: $20 to $28 per hour based on qualifications.
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