1+ months

Engineer II/Senior Engineer, Process Automation (Frontline)

Vacaville, CA 95688

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, weve become one of the worlds leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients lives. We are courageous in both decision and action, we believe that good business means a better world.

The focus of the Vacaville Operations Facility is Drug Substance bulk manufacturing. We have a passion for science, technology, innovation, professional development, and diversity and inclusion. We are also deeply respected for our unique and special culture; one that centers around the people we attract and hire. Our Pharma vision is to have a greater overall patient benefit and impact. This focus includes personalized healthcare, designing the processes with the patient in mind, and improving their quality of life. We hope you consider joining our team and being a part of one of the largest biotechnology facilitiesin the world!

Job Summary:

Candidate provides automation support to the Vacaville CCP1 (Cell Culture Plant 1) Manufacturing Operations as part of the Process Automation group, focused on the DCS (Distributed Control System Siemens APACS control layer with Aveva InBatch and ArchestrA batch and SCADA layers) to implement continuous improvement changes, support MAR (Make Assess Release) activities, and lead and / or assist with expense / capital projects.

Responsibilities include:

  • Work with Manufacturing, Quality, F&E (Facilities and Engineering), and MSAT (Manufacturing Science and Technology) departments to implement corrective actions and continuous improvement changes, and lead/support expense /capital projects.

  • Develop, review and approve applicable automation-related specifications and any other related documentation.

  • Perform off-line and on-line configuration, code reviewing, testing, and procedure execution related to baselining or migration of software between environments.

  • Support design, development and execution of Automation Change Records (ACRs) and commissioning / qualification test documentation.

  • Perform troubleshooting of process, equipment, and system malfunctions or failures involving the DCS, including off shift hours (mandatory on call rotation) as required.

  • Perform detailed reviews of executed ACRs and tests for completeness and accuracy.

  • Perform quality discrepancy evaluations/assessments and provide support for investigations.

  • Assist with equipment testing and debug activities.

  • Review and assess change records, risk assessments, and user requirements.

  • Represent automation engineering on multidisciplinary and cross-functional project teams.

  • Perform cGMP reviews of executed Automation Work Plans and tests for completeness and accuracy.

  • Mentor incoming automation engineers, consultants, interns or rotational personnel.

Job requirements

  • BS or MS Degree in Chemical, Electrical Engineering, Mechatronic Engineering, Mechanical Engineering, or Computer Science or equivalent training.

  • For Engineer II: Minimum of 5 - 8 years of related experience, preferably in the Bio-Pharmaceutical, Pharmaceutical, food or other batch processing industries. For Senior Engineer level: Minimum of 8 - 11 years of related experience, preferably in the Bio-Pharmaceutical, Pharmaceutical, food or other batch processing industries.

  • Working experience with DCS, software development methodologies and automated systems life cycle support in a regulated industry. Knowledge of Emerson DeltaV architecture, software programming, and communication protocols is preferred but not required.

  • Systematic knowledge of Automation Society (ISA) Standards S88 and S95 as well as the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP) Guide to the Validation of Automated Systems.

  • Thorough understanding of cGMPs (current Good Manufacturing Practices), particularly as they relate to the operation, validation and maintenance of computer-controlled systems.

  • Comprehensive understanding of engineering techniques and principles and the ability to apply said knowledge as required.

  • Thorough knowledge of I&E (Instrumentation and Electrical), such as networking, architecture (including panels), IO / device configuration, and wiring diagrams.

  • Solid knowledge of scripting as it relates to automation-based DCS databases / software programs, such as C#, Python and/or VB.net.

  • Certifications such as CAP, P.E., or PMP preferred but not required.





Posted: 2021-06-16 Expires: 2021-08-15

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Engineer II/Senior Engineer, Process Automation (Frontline)

Vacaville, CA 95688

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