1+ months

Engineer I, Laboratory Operations (Contract position)

California, CA

Please note this is a contract position for approximately one year (12 months)

Job Title: Engineer I, Laboratory Operations

Executive Summary:

  • Engineer supporting new product design, development, and implementation of drug delivery devices and novel combination products. Primary technologies include implants, auto-injectors, patch pumps, needle systems, and pre-filled syringes.

  • Bridge Early Stage and Late Stage medical device development from Research & Development to Design Verification and clinical/commercial product support.

  • Determine testing strategy during development and execution of Test Protocols and Test Methods. Leverage mechanical and analytical testing data to support the selection, Design Verification, commercialization, and marketing of various medical devices and combination products.

  • Work with Device Engineers, Process Engineers, and the Laboratory Supervisor to identify, develop, implement, qualify and validate new test methods, procedures, and processes.

Research & Development (R&D) Engineering Activities:

  • Conduct R&D testing activities:

    • Conduct Research & Development engineering activities, statistical analyses, and Design of Experiments (DoE) for both ad-hoc characterization and/or Technical Studies.

    • Author and/or review Test Methods, Testing Protocols, and Technical Plans.

    • Design and Rapid Prototyping of test fixtures, as needed.

Design Verification (DV) Engineering and other GMP Activities:

  • Develop, review, plan, and execute GMP Protocols (Design Verification, Test Method Validation, and Complaints Investigations):

    • Execute GMP (e.g. DV) activities using specialized knowledge of Design Input Requirements, Validated Test Methods, and analytical instruments.

    • Report Out of Specification (OoS) results and atypical events that occur during GMP activities.

  • Report GMP Data to Device Teams to support data analysis and report writing:

    • Record GMP data for Design Verification in Laboratory Notebook and Document Control systems.

    • Review GMP data for technical accuracy, completeness, and PQS compliance.

  • Ensure Pharma Quality System (PQS) Compliance during Verification Engineering activities:

    • Document training during GMP lab activities (e.g. DV Testing).

    • Collaborate with the equipment and instrument groups to maintain lab infrastructure for qualified instruments and validated methods.

    • Ensure adherence to applicable Genentech/Roche cGDP standards for data documentation, review, and reporting.

PQS Compliance & Safety Assurance Activities:

  • Ensure Laboratory Safety & PQS Compliance via regular self-audits:

    • Establish baseline for PQS compliance and Safety standards:

      • Ensure compliance for qualified equipment, samples, chemicals, materials, etc.

      • Document non-compliance and communicate with lab users to ensure timely remediation of findings.

      • Measure trends and support Root Cause Analysis (RCA) to suggest solutions to Laboratory Supervisor for mitigation of repeated findings and closure of quality system gaps.

    • Coordinate with Safety Team:

      • Conduct audits to assess Safety Compliance and report on results of audits.

  • Resolve PQS non-compliance related to laboratory processes, equipment systems, Out-of-Specification (OoS) test results.

    • Appropriately document OoS test results and atypical events.

    • Create action plans or perform Design of Experiments for resolution, as needed.

Inventory and Material Management

  • Materials Management (GMP and R&D)

    • Forecast demand for allocating laboratory and storage space.

    • Execute GMP Environmental Monitoring activities including, but not limited to: alarm checks, equipment inspections, supplemental temperature monitoring, and documentation.

    • Maintain and audit digital and paper-based Inventory Systems.

Continuous Improvement (CI) and Lean Production Systems (LPS) Implementation Activities:

  • Train in LPS methodology and consistently practice lean principles in daily work within Device Development Laboratory.

  • Implement and maintain 5S within Device Development Laboratory.

  • Conduct Value Stream Mapping of laboratory processes to identify waste, promote process efficiency, and develop CI ideas.




Technical Knowledge:

  • B.S. degree in an engineering field (mechanical, biological, biomedical, chemical) or equivalent.

  • 2-3 years experience in the Pharmaceutical, Biotech, or Medical Device industry is required. Direct experience in developing and executing physical/functional Test Methods and reviewing /authoring SOP and Test Protocols is highly desired.

  • Experience in R&D and GMP environments is preferred, and an understanding of the differences between these environments is critical.

  • Familiarity with design principles, design of experiments, design controls, URs/DIRs, 3D modeling software (CAD) and rapid prototyping instrumentation is highly desired.

  • Must have engineering expertise in electrical/mechanical instrumentation, data acquisition, data recording, and data integrity.

  • Familiarity with statistical software (JMP, Minitab) and analysis techniques is a plus (risk analysis, sample size determination, normality testing, summary statistics, data visualization).

  • Familiarity with tensile/torque testing systems is highly desired (Instron, Zwick, Mecmesin)

  • Familiarity with dimensional analysis/metrology equipment is highly desired (Microscopes, Gages, Calipers, Vertex).

  • Familiarity with Operational Excellence Initiatives, Lean Six Sigma, 5S, Kaizen, and/or Value Stream Mapping is a plus.

Interpersonal Skills:

Must be highly organized and detail oriented. Able to conduct work on multiple projects with precision.

Team oriented, creative, eager to take on responsibility, and implement change dependable.

Excellent written and verbal communication skills are required.

Demonstrated ability to communicate with internal stakeholders and external collaborators.

Posted: 2018-12-20 Expires: 2019-03-21

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Engineer I, Laboratory Operations (Contract position)

California, CA

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