Frontline Automation Engineer, MAR Support

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The Opportunity:

In this role, you will provide automation support to the manufacturing operations as part of the Frontline MAR Support Team. You will be responsible for troubleshooting events, managing planned changes, and executing small to medium-complexity improvement projects. You will work with a highly capable, cross-functional team including members of Manufacturing, Process Engineering, Maintenance, System Owners, SHE, and Quality Assurance groups. You will use technical knowledge, leadership skills, and your advanced understanding of GMP systems to identify and solve complex problems, make and influence decisions, and deliver results.

Who you are:

• The Automation Lead for one or more unit operations across functional departments to drive efficient issue resolution and change implementation.
• Provide technical assessments of proposed changes from other departments and evaluations of discrepancies that occur during manufacturing operations.
• Serve as the automation representative across functional departments at various levels to drive efficient issue resolution and change implementation.
• Reviews and provides input to the development of policies and standards for the Automation Discipline at the site
• Participates in the development and implementation of new ways of working within Automation that improve both the level of quality and efficiency of the Automation Team
• Investigate automation events using formal problem-solving tools to determine root cause(s)

Who you are:

• Bachelor's Degree in Chemical, Mechanical, or Bio-Chemical Engineering is preferred

• Working experience with software development methodologies and automated systems life cycle support in a regulated industry.
• Knowledge of Good Manufacturing Practices (cGMPs), S88 and GAMP, particularly as they relate to the operation, validation, and maintenance of computer-controlled systems.
• Understanding of engineering techniques and principles and the ability to apply that knowledge as required.
• Thorough working knowledge of the Food and Drug (FDA) Code of Federal Regulations (CFRs) and the European Medicines Authority (EMA) including the International Council of Harmonization (ICH) regulations

**Work Environment/Physical Demands/Safety Considerations

• Clean room environment with large mechanical equipment
• Requires gowning (scrubs, coveralls, gloves, safety shoes) to be in clean rooms
• Rotating on-call assignments to support plant operations after hours
• May work in the presence of hazardous materials to support operations
• Physical demands may require lifting up to 40 pounds due to automation system hardware failures and installation.

The expected salary range for this position based on the primary location of Vacaville, California:

• Frontline Engineer - $72,000 - $102,000 max - 3+ years experience
• Sr Frontline Engineer - $106,000 - $150,000 max - 8+ years experience

Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Job descriptions are not intended, and should not be construed, to be all-inclusive lists of all responsibilities, skills, efforts, or working conditions associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add, or remove duties and to assign other duties as necessary.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.