Bioprocess Engineer

Job Title – Bioprocess Engineer

Location - San Diego, CA

Duration – 12+ Months Contract

Total Hours/week - 40.00
The work hours is 40 hr/week with 75% travel to San Jose CA
It is an onsite position.

Temp to Full Time possible.

3 must haves on the resume: Wet chemical bench experience, bioconjugation, 8+ years’ experience after BS degree.

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 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

Minimum Qualifications
Education and Experience:
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.

Assets:
Biochemistry, Microparticles, Bioconjugation, Polymer, Organic Chemistry