drjobs BioprocessNPI Engineer

BioprocessNPI Engineer

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Job Location drjobs

San Diego, CA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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: MidLevel

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:

  • Indepth 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 indepth 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 SOPs WIs BOMs 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 (VRs) 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 (COs)
  • 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 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 bachelors degree with 7 years of experience; Or a masters 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

Employment Type

Full Time

Company Industry

About Company

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