Bioprocess/NPI Engineer
Company: millenniumsoft
Location: San Diego
Posted on: April 1, 2026
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Job Description:
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
Keywords: millenniumsoft, Santee , Bioprocess/NPI Engineer, Science, Research & Development , San Diego, California
