Engineer III

5 - 7 years experience  • 

Salary depends on experience
Posted on 03/27/18
5 - 7 years experience
Salary depends on experience
Posted on 03/27/18

Responsibilities

  • Perform, evaluate and analyze validation protocols and associated data for compliance with FDA and ISO guidelines
  • Evaluate and analyze validation data collected during projects, verify the adequacy of the data and compliance with regulatory requirements
  • Plan and conduct experiments to fully characterize the process. Analyzes process variables and data collected to identify critical parameters optimize processes and equipment performances
  • Demonstrate technical capability in the area of manufacturing process evaluation, critical process parameters identification & selections
  • Manage equipment & process validations, tooling and fixture development and documentation, creation and updating of procedures and drawings
  • Manage development and execution of engineering validation & qualification protocols, IQ/OQ/PQ, reports, equipment requirements, safety evaluation documents
  • Proactively review validation status of current equipment, systems, utilities and facilities in order to perform documented periodic validation assessments, risk analyses and identify remedial activity.
  • Experience with Statistical Analysis and Process Control (Gauge R&R,CP, CPK, ANOVA), Design of Experiment (DOE), and PFMEAs
  • Demonstrate ability in implementing the DMAIC methodology to solve and correct problem, measuring the effectiveness of the implemented actions. Use of root cause investigation tools and statistical tools
  • Knowledgeable in cleaning and sterilization validation of manufacturing equipment a plus

Qualifications

  • Bachelor’s degree or equivalent in a related engineering discipline
  • 5+ years experience or equivalent combination of education and experience
  • Process & equipment development, validation and qualification a must
  • Project management
  • ISO 13485, medical device risk management ISO 14971, FMEA, ECO, CAPA, NCR, RCA
  • Lean manufacturing, Six Sigma and Minitab statistical tools (SPC, Gage R&R, DOE, etc.)

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

 Requisition ID 2018-6296

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