What are the responsibilities and job description for the Bioprocess/NPI Engineer position at MillenniumSoft Inc?
Position : Bioprocess/NPI Engineer
Location : San Diego, CA
Duration : 12 Months
Total Hours/week : 40.00
1st shift
Client: Medical Device Company
Job Category: Healthcare
Level Of Experience: Mid-Level
Employment Type: Contract on W2 (Need US Citizens, GC Holders Only)
The work hours is 40 hr/week with 75% travel to San Jose CA
3 Must Haves On The Resume
Wet chemical bench experience, bioconjugation, 8 years’ experience after BS degree.
Job Description
Education and Experience:
Location : San Diego, CA
Duration : 12 Months
Total Hours/week : 40.00
1st shift
Client: Medical Device Company
Job Category: Healthcare
Level Of Experience: Mid-Level
Employment Type: Contract on W2 (Need US Citizens, GC Holders Only)
The work hours is 40 hr/week with 75% travel to San Jose CA
3 Must Haves On The Resume
Wet chemical bench experience, bioconjugation, 8 years’ experience after BS degree.
Job Description
- In-depth knowledge of product development, extensive experience in scale up, process improvements, validation, and transfer of production processes to Operations.
- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment in determining the scope and timing of transfer activities.
- Exercises judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
- Responsible for improving process efficiency and product quality. Determines methods and procedures on new assignments.
- Represents Reagent operations in new product teams as the core team member. With minimal supervision and assistance, transfers products and processes into manufacturing following the Global Product Development System
- Develops strategies and carries out plans to stabilize and reduce production cost of new products
- 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 mentor’s 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
Education and Experience:
- Requires a bachelor’s 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.
- Biochemistry, Microparticles, Bioconjugation, Polymer, Organic Chemistry