14 days old

Qualification Engineer

Lodi, CA 95240

Position Overview:

This position supports all departments at the Cepheid Lodi Operations Site through collaboration with site leaders and project managers to develop, plan and execute qualification and validation protocols for manufacturing equipment, automation systems and processes. These protocols are required to be in compliance with Cepheid Quality System€™s regulations involving thorough and rigorous documented tests, resulting in a robust and repeatable process making products which meet all internal and external safety, purity and quality requirements.

This individual must be capable of working in an interdisciplinary environment as a contributing team member and independently on a wide variety of projects.

Roles, Responsibilities, and Expected Results of Position include, but are not limited to:

  • Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.
  • Author startup, commissioning, and qualification test protocols (IQ/OQ/PQ) for manufacturing equipment, automation systems, software and processes.
  • Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
  • Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
  • Execution of qualification/validation protocols working with various Lodi Site departments including identification and resolution of non-conformances/deviations.
  • Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
  • Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
  • Complete, compile, review and submit all protocol documentation and submit for cross-functional approval.
  • Prepare, maintain, or review validation and compliance documentation such as planned deviation requests, engineering change notices, schematics, or protocols.
  • Assist in training equipment operators or other staff on validation protocols and standard operating procedures.
  • Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
  • Draw samples of raw materials, or intermediate and finished products for validation testing.
  • Resolve testing problems by modifying testing methods or revising test objectives and standards.
  • Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
  • Procure or recommend automated lab validation test stations or other test fixtures and equipment.
  • Maintain validation test equipment.
  • Continuously improve site process validation program by:
    • Ensuring compliance with corporate guidelines and FDA requirements 
    • Networking with counterparts at other manufacturing sites to share best practices
    • Evaluating impact of procedural and equipment changes on process validation


      • Bachelor's degree in field with 5+ years of related work experience or Master's degree in field with 3+ years of related work experience.
      • Extensive experience with validation activities such as equipment qualification (IQ, OQ, and PQ)
      • 5 years€™ experience in a Medical Device Manufacturing Environment regulated by FDA
      • Six Sigma, Lean, 5S, Kaizen process improvement project background
      • Excellent organization, communication [speaking and listening] and computer skills
      • Minimum requirement
      • Injection Molding Experience


        • Engineering Degree
        • Project Management Professional [PMP] certification
        • CAD software experience [SolidWorks, AutoCAD, Pro/E]


          • Light duty office and cleanroom working environment
          • Sitting at computer workstation
          • Walking throughout factories to gather information and communicate with key team members
          • Some part and equipment inspection


            • N/A


              • 2-5% of time to Sunnyvale


                Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Biotechnology


Posted: 2020-05-21 Expires: 2020-06-20

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Qualification Engineer

Lodi, CA 95240

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