Position : Bioprocess/NPI Engineer

Location : San Diego, CA

Duration : 12+ Months

Total Hours/week : 40.00

1^st 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.

Duties And Responsibilities

• 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

Minimum Qualifications

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.

Assets:

• Biochemistry, Microparticles, Bioconjugation, Polymer, Organic Chemistry