Senior Data & Analytics Engineer

Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? Are you curious to shape a digital manufacturing architecture, ready to advance competitiveness on the market?

We Make Medicines!

Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as using new technologies.

This position, based in Genentech's Oceanside, California facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance and drug product manufacturing facilities. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate will report to the Head of ITOT at the site.

What you'll be working on:

• Development and lifecycle management of the data historian and related data systems in a GMP regulated environment.
• Driver for reliability and continuous improvement for data systems, tools and reports
• Perform application administration (user admin, patching, upgrades, audit support, system and database log review and maintenance)
• Contribute to the design and development of new data tools to meet business requirements and implement enhancements in support realization of the roadmap and provide access to manufacturing data for support groups.
• Software development in various languages, testing and configuration of COTS or custom applications to support SSF Manufacturing systems and support of stakeholders including PTD, EEA, Operation, F&E and Quality groups in efficiency and productivity driven initiatives.
• Support the execution of computer system validation and system lifecycle management as appropriate.
• Monitoring and analysis of manufacturing data as necessary to provide support for process discrepancies, investigations, validation protocols, process transfers, or equipment troubleshooting
• Work to identify opportunities to create additional value and improve business processes and patient outcomes, maximize the benefits of standardization of technologies and leverage across sites.
• Troubleshoot and resolve incidents and problems associated with the system/databases and applications.
• Through Agile delivery model, provide technical expertise and local implementation experience as a member of Build and Run Squads.
• Execute implementation and delivery of projects on-site IT OT Product Portfolio

• Assist in development of end-user and maintenance training materials.
• Provide diagnostic troubleshooting assistance to maintenance and technicians as required, including off-hour and on-call support.
• Capable of working independently, effective at managing multiple tasks and projects, flexible and able to adapt quickly to new and changing situations.
• Lead or coordinate technical discussions and vendor negotiations.
• Present to auditors during internal audits and regulatory inspections.
• Mentor junior engineers to develop their skills.
• Lead cross-functional projects or teams of moderate scope and drive project/process improvements.
• Advanced organizational and technological capabilities.
• Develop solutions to complex problems requiring the regular use of ingenuity and innovation.
• Skilled at providing end user support in a complex, 24x7 environment. Available for on-call support

The ideal candidate:

Has business domain knowledge for the following area(s)

• Biopharmaceutical or similar Manufacturing domain.
• Advanced knowledge of data management solutions such as AVEVA PI System
• Advanced knowledge of data management integration technologies such as OPC standards, PI connectors, PI interfaces, MQTT, RDBMS, XML, JSON, REST API, etc. is a huge plus.
• Knowledge of operational analytics tools such as PI Vision, SEEQ is a plus.
• Knowledge of computer systems, relational databases, and experience utilizing Windows/Linux, PL/SQL, JavaScript, HTML, Python, and/or other programming platforms highly desirable.
• Knowledge of Manufacturing Execution Systems (Pharmasuite or Syncade), Manufacturing Control Systems (Emerson or Rockwell), LIMS, and SAP considered a plus.
• Advanced knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles.
• Exhibits intellectual curiosity and integrity and has a strong passion to bring value-adding technology to the business.

Requirements:

• Bachelor's Degree in Informatics, Engineering or equivalent.

• 5+ years of experience implementing and managing data and/or analytics solutions. Highly desirable AVEVA PI Data Historian experience or experience from other platforms that will accelerate learning on those platforms.

• Prior experience in working closely with IT OT providers/vendors.

Relocation assistance will be considered for exceptional candidates

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