Engineer I

California, United States of America

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The Position

  • Technical leadership and/or support of GMP processes, process analysis and process equipment:
    • Having a customer service mindset to provide technical leadership supporting manufacturing operations through process monitoring, trouble shooting of processes to ensure the health of the process and equipment.  Have the ability to identify issues, analyze the potential risk, formulate and implement corrective actions.
    • Uphold quality standards by ensuring compliance with Pharmaceutical Quality Systems and with Global Standards and Process; providing technical leadership to ensure the efficacy of risk assessments, providing technical support for complex investigations, CAPAs and quality discrepancy while driving closure to timelines.
    • Provide technical leadership for the tech transfer of new and commercialized products by leading facility fit, process capability and process gap analysis.  Leading cross-functional teams to execute process characterization and support regulatory filings.   
    • Have the ability to author and/ or provide guidance for the authoring of controlled documents to support process validation, equipment commissioning, and qualification of equipment and complex systems.
    • Participate in cross function teams to support expense/capital projects through design, construction, implementation, commissioning and qualification activities; with the ability to provide guidance and oversight of contract staff.  Participate in system and equipment design, utilizing engineering documentation such as PFDs, P&IDs, URSs, Design Specifications, data sheets, piping isometrics, Installation/ Operation Qualification, Process Qualification and Process Validation.
    • Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Fosters a positive safety culture in which no one gets hurt.
    • Interact with vendors to assist in projects, trouble shooting and investigations.  Review vendor information packages, including drawings and specifications. 

  • Supplementary Responsibilities:
    • Have the ability to participate in cross functional teams to coordinate activities and provide engineering leadership.
    • Participate in cross functional teams representing Process Engineering as the technical steward of the process and process equipment.
    • Participate on global teams to implement network initiatives at the local level.
    • Have the ability to support senior staff to drive outstanding items to closure without compromising quality.
    • Have the understanding of automated processes, instrumentation and control systems.
    • Present data and concepts at department, project team and other meetings within company and at outside conferences.
    • May provide direction to sub-contracting groups in the design and installation of process and clean utility systems.  Participate in the design specification testing and execute field studies.

Job Requirements

Education and Experience

  • Bachelor’s or Master’s degree in Engineering (Chemical or Electrical preferred) and 5 years of experience, or Master’s degree in Engineering (Chemical or Electrical preferred) and 4 years of experience.
  • Minimum of 5 years applicable instrument and control system experience.
  • Minimum of 3 years in the pharmaceutical/biotech industry/GMP experience.

Knowledge, Skills and Abilities

  • Knowledge of cGMP guidelines and familiarity in working with controlled documents.
  • Ability to comply with cGMP requirements to work in clean manufacturing spaces, i.e., gowning protocols, documentation and procedures.
  • Experience in process monitoring and process capability.
  • Ability to review process data, analyze trends and make process recommendations.
  • Ability to assess impact of changes on the process and equipment.
  • Experience in the design, installation and operations of GMP process equipments.
  • Validation/Commissioning experience of large scale process equipment and systems.
  • Ability to generate engineering design drawings and specifications.
  • Ability to perform validation and/or engineering studies and analyze the results to write formal reports.
  • Understanding of clean/aseptic manufacturing process and equipment.
  • Demonstrate good organizational and time-management skills.
  • Demonstrate strong interpersonal skills including the ability to interact with individuals of various backgrounds and levels of technical expertise.
  • Demonstrate strong written and verbal communication skills.
  • Ability to work in a fast-paced environment including the ability to adapt to changing priorities as necessary to achieve department and corporate goals within established timelines.
  • Ability to communicate technical issues to a diverse group, ranging from process scientists to field technicians.
  • Demonstrate the ability to make decisions using excellent business and technical judgment.
  • Ability to comply with cGMP requirements to work in clean manufacturing spaces, i.e., gowning protocols, documentation and procedures.
  • Demonstrate proficiency in word processing, spreadsheet, database, project management and presentation software applications.
  • Demonstrate a high-degree of analytical and problem-solving skills, with emphasis on very technical issues relating to process controls, automation systems, and general control theory.

Work Environment/Physical Demands/Safety Considerations

  • Work in standard office environment.
  • May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.  Also, no make up or jewelry can be worn when working in the clean room environment.
  • May work with hazardous materials and chemicals.

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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