Senior Reliability Engineer

The Position

Our Oceanside facility is a multi-product CHO drug substance manufacturing site with parallel commercial production and launch capabilities.

The reliable operation of our equipment and systems is fundamental to successfully operating the Oceanside biologics drug substance manufacturing plant. The Reliability Engineering team monitors the equipment maintenance and repairs to ensure that our equipment is maintained with the highest possible uptime at the optimal cost. The team uses the latest tools, technologies and techniques, including Predictive Maintenance and numerous maintenance indicators, to continually monitor and adjust (optimize) the maintenance program.

The Reliability Engineer proactively collects and analyzes plant reliability and downtime data from various sources to identify current and potential defects working in collaboration with Maintenance Operations, Quality and Engineering. They optimize asset reliability, availability, longevity and operational safety through application of Reliability Centered Maintenance (RCM) strategies and techniques for our manufacturing process equipment as well as sitewide utility systems (HVAC, water, steam, etc). Using this data, they collaborate with cross-functional teams to develop the rationale and business case for program adjustments and/ or asset modifications/ replacements. Provides technical leadership to the Reliability Engineering Group in Oceanside and provides changes to equipment or business processes. Provide technical leadership in directing business/RE leaders to develop RE & TPM deployment strategies, identify process improvement opportunities that are linked to long-term business strategies, ensuring that the Maintain to Improve business process is successful and improving.

Job Responsibilities

• Analyze historical maintenance and operational data and identify trends.
• Establish data-driven maintenance improvement recommendations.
• Collaborate with other sites to identify and implement Reliability best practices
• Resolve and present reliability defects by removing validated root causes and verifying effectiveness of solutions.
• Lead Equipment End Life Evaluation (ELEE) program.
• Employ the Lean, DMAIC, EDO and Change Realization methodology to deliver business results
• Prioritize and document system reliability issues and provide input into Engineering on recommended modifications for existing equipment.
• Supports timely closure of facility related cGMP deficiencies including audit observations, corrective and preventative actions (CAPA) and deviations.
• Assist with new equipment design, purchase specifications/ decisions and installation qualification criteria.
• Sponsor project teams that utilize proven process improvement methodologies (e.g. Lean, Six Sigma, Kepner Tregoe, EDO, Change Realization, etc.) to deliver business results (customer satisfaction, quality, reliability, productivity, and safety)
• Review and approve vendor information packages, including drawings and specifications and make recommendations.
• Develop, manage and integrate key aspects of critical projects such as budget, schedules, resource planning, problem solving, etc, in alignment with corporate objectives.
• Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and complex systems.
• Provide key input into the validation of process equipment and associated utilities.
• Ensure business fundamentals reports and other status updates are readily available to the Site Leadership Team as required.
• Fosters a positive safety culture in which no one gets hurt.
• Provide technical assessments for investigations and manage corrective actions as a result of investigations.
• Supervise external consulting engineers and provide process overview and review drawings and documents produced by these groups.
• Interact with vendors concerning contracts of critical financial value and select vendors based on the most appropriate combination of price, quality and delivery.
• Provide support and input for the Reliability Roadmap.
• Prioritize findings on data and communicate findings on a routine basis to management and customers.
• Facilitate department meeting as necessary to keep staff apprised of project status
• Attend seminars and/or classes as necessary to meet technical and/or business demands
• May determine methods and procedures necessary to operate new equipment
• Good understanding of Predictive Maintenance (PdM) methods such as oil analysis, thermography, vibration analysis, etc.
• Facilitate Failure Modes and Effects Analysis (FMEA) and Root Cause Analysis (RCA) on production and utility equipment and systems
• Recommends to manager work priorities, timelines and resources
• Continuous-improvement mindset, always driven to challenge and improve
• Demonstrates judgment in selecting methods and techniques for obtaining solutions
• Represents organization on assigned projects
• 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. Oversee design specification testing and perform field inspection services
• May propose ideas for new programs in alignment with strategic planning
• Regularly apply theories and principles from one's technical / professional discipline to independently address a variety of problems of moderate scope
• Good understanding of Predictive Maintenance (PdM) methods such as oil analysis, thermography, vibration analysis, etc.
• Facilitate Failure Modes and Effects Analysis (FMEA) and Root Cause Analysis (RCA) on production and utility equipment and systems
• Data collection and data evaluation
• Use judgment and discretion to solve a variety of problems of moderate scope and complexity
• Utilize DMAIC (Define, Measure, Analyze, Improve, Control) or KT analysis processes to assist with making sound decisions based on facts

Job Requirements

Education and Experience

• Bachelor's degree in Engineering 4-6 years experience in a corporate environment
• Minimum 3 years' experience with applicable certifications and Professional engineering license
• Understand and operate automation control systems preferred
• Ability to generate standard operating procedures required
• Ability to generate engineering design drawings and specifications required
• Demonstrate good organizational and time-management skills required
• Thorough understanding of cGMP manufacturing operations required
• Excellent analytical, communication, presentation, and computer skills req
• Excellent customer service skills
• Ability to multi-task and effectively organize responsibilities to achieve portfolio goals and objectives
• Team oriented, flexible and able to work well in cross-functional settings
• Knowledge of process, utility and building control systems

Work Environment/Physical Demands/Safety Considerations

• Works in a standard office environment
• Proven experience analyzing historical maintenance and operational records using desktop tools, including developing novel analysis techniques
• Practitioner of multiple root cause analysis techniques
• Demonstrated ability to apply Subject Matter Expert (SME) skills and experience to investigate system deficiencies (design, operational and maintenance related)
• 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
• Maybe exposed to hazardous materials and chemicals
• Experience with SAP-PM is strongly preferred
• Ability to comply with cGMP requirements (gowning, documentation and procedures) for performing work within a manufacturing facility

Relocation is not approved for this posting.

The expected salary range for this position based on the primary location for this position of California is $100,500 - $186,600. 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

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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.

Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

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. For more information about equal employment opportunity, visit our Genentech Careers Homepage.