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Failure Investigation Engineer, Bangalore

This position is part of Cepheid and location preference is Bengaluru.

Role: Failure Investigation Engineer

Essential Job Responsibilities:

  • Support manufacturing in first-line investigations of product or process failures.
  • Drive failure investigations elevated from customer complaints, statistical process trending, or stability studies.
  • Support improvement projects resulting from root cause investigations.
  • Lead brainstorming and other root cause analysis techniques.
  • Participate or lead PSPs (Problem Solving Processes).
  • Design and execute experiments as part of investigations.
  • Work with cross-functional teams to provide knowledge and support to NPI (New Product/Process Introduction) or Sustain and Support projects.
  • Use product software and other software tools as part of testing.
  • Develop new test methods and tools for failure investigation use.
  • Continuously document progress during investigations and prepare final reports.
  • Prototype and evaluate mitigations and corrective actions.
  • Analyze historical data to identify abnormal trends.
  • Perform failure trending and analysis on key performance metrics of various products and compile data for team review.

Training Responsibilities (Required):

Completes all assigned and required training satisfactorily and on time.

Minimum Requirements:

  • Education and Experience (in years):
    • MSc in Molecular Biology or similar Life Sciences or MSc Biotechnology or minimum of 3 years equivalent work experience to perform at this level.
  • Knowledge and skills:
    • Proficiency in molecular biology and real time PCR.
    • Experience in data analysis, product inspection, design of experiments, software engineering and automation including scripting, root cause analysis techniques, and documentation according to GMP.
    • Knowledge of Cepheid’s products, manufacturing, and release processes.
    • Ability to work independently and cross-functionally to provide effective updates at an executive level.
    • Good skills in Excel.
    • Excellent organizational skills.
    • Excellent communications skills written, oral, and presentation.
    • Experience with statistical analysis and data management for large volume complex datasets.
  • Physical requirements/abilities:
    • Ability to work in an office, laboratory, and production environment.
    • Flexible to work in shifts and weekends.

Preferred Requirements:

  • Experience in root cause analysis techniques.
  • Working experience in a manufacturing environment.
  • Working experience in a global environment.
  • Working experience in a support organization.
  • Experience in working in a regulated environment (ISO, GMP).

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Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.