Engineer I, Laboratory Operations

South San Francisco
California, United States of America


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The Position

The Engineer I will support new product design, development and implementation of delivery devices and novel injection tools/aids for biologic therapeutics. Primary technologies include auto-injectors, patch infusers/pumps, and needle stick prevention devices utilizing pre-filled syringes and cartridges. This individual will work with Laboratory/Device/Process Engineers and the Laboratory Manager/Supervisor to develop and implement new laboratory processes/procedures, maintain and qualify new testing equipment, and validate and execute methods.

Responsibilities

Testing and Development

  • Develop, author and/or review Testing Protocols/Plans for Design Verification (DV), Test Method Validation (TMV), and Equipment Qualification (EQ) using specialized knowledge of User/Design/System Requirements, Test Methods, and analytical instruments
  • Execution of routine and non-routine mechanical and analytical testing to support the development, verification, commercialization and marketing of various device designs. Testing includes: device long-term functionality, DV, EQ, TMV, and other special test requests (e.g. complaints investigation, method transfer/migration, system upgrades)
  • Develop, author, revise, and/or review Test Methods, Operating Procedures, Work Instructions and templates under Technical Change Management system
  • Development, design and rapid prototyping of test fixtures, as needed
  • Support equipment/accessories purchasing activities, maintain equipment calibration/qualification status and inventory lists, troubleshoot equipment failures, conduct periodic reviews, support vendor on-site services, and ensure data integrity
  • Manage samples/materials (R&D and GMP), coordinate and document sample transfers to ensure traceability, and regularly communicate with sample owners to forecast demand. Work with the Lab Manager/Supervisor to allocate storage and laboratory space
  • Develop training modules and provide training on equipment use, laboratory procedures/methods, and laboratory use/safety to the laboratory users
  • Support the Laboratory and Device Teams in data review, analysis, and interpretation
  • Identify and Report out of specification results, data, and atypical/unexpected events that occur during GMP activities and support associated investigations, impact assessments and Root Cause Analysis (RCA)
  • Conduct ongoing Regulatory Compliance & Safety Assurance activities as assigned by the Lab Manager/Supervisor. Activities include maintaining cGDP/GLP compliance for documents, data, equipment, samples, chemicals, materials, and training status on laboratory and safety procedures to ensure Audit-readiness

Quality Systems Compliance

  • Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department
  • Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents
  • Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices
  • Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions
  • Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate
  • Support the laboratory lead in preparing communications for internal review committees
  • Ensure compliance of training to PQS and job-related requirements
  • Work with limited direction.  Provide guidance and coordinate work activities with other personnel

Requirements

Education

  • B.S. degree in an engineering field (mechanical, biological, biomedical, chemical) or equivalent and 2+ years of experience. Pharmaceutical, Biotech or Medical Device industry is preferred

Technical Knowledge:

  • Direct experience in developing and executing physical test methods, procurement and qualification of equipment, development and validation of test methods, and authoring/reviewing procedures and protocols
  • Experience in R&D, GLP and GMP environments is preferred, and an understanding of the differences for these environments is critical
  • Experience in design principles (Design Controls, URs/DIRs, Design for Manufacturability) and development of test fixtures (CAD, rapid prototyping, GD&T, material selection)
  • Expertise in electrical/mechanical instrumentation, data acquisition, maintenance and data integrity
  • Familiarity with Operational Excellence Initiatives, Lean Six Sigma, 5S, Kaizen, and/or Value Stream Mapping is a plus
  • Familiarity with tensile/torque testing systems (Instron, Zwick, Mecmesin) and/or dimensional analysis/metrology equipment (Microscopes, Gages, Calipers, Vertex) is highly desired
  • Familiarity with statistical software (JMP, Minitab) and analysis techniques is a plus (risk analysis, sample size determination, normality testing, summary statistics, data visualization)

Interpersonal Skills:

  • Must be highly organized and detail oriented
  • Ability to conduct work on multiple projects with precision
  • Dependable, team oriented, creative, eager to take on responsibility, and implement change
  • Excellent verbal and written communication skills are required
  • A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment

We are only considering local candidates at this time.

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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