Process Engineer II, Utilities

United States of America, California, Vacaville

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Please note there are multiple positions available

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s 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 facilities in the world!

Job Summary:

Facilities and Engineering seeks a competent and energetic Process Utility Engineer to work closely with Roche/Genentech Corporate Engineering, your colleagues in Facilities and Engineering, Manufacturing Department, Security, Safety Health and Environmental (SHE) Department and Quality Department in troubleshooting, evaluating, problem solving, and optimizing of the utility systems at the Vacaville Manufacturing Facility.

 

Reporting to the Utilities Senior Manager within the Front Line Engineering department and supported by other senior engineers to provide engineering support to the operations in Vacaville. Engineering supports the Utility areas and may include the following responsibilities:

  • Collaborate with Roche/Genentech Corporate Engineering, your colleagues in Facilities and Engineering, Manufacturing Department, Security, Safety Health and Environmental Department and Quality Department to ensure successful implementation of facility modifications, process expansions, and new construction

  • Immediate resolution of emergent issues; including troubleshooting process, equipment, and system malfunctions or failures on a 24/7 basis, to include weekends and holidays as necessary

  • Daily process monitoring and analysis of manufacturing data, engineering evaluation and support for discrepancy investigations, and identification/implementation of immediate corrective or preventative actions to ensure continued compliant operation

  • Support Roche/Genentech’s Right to Operate and to Make, Assess, and Release our pharmaceuticals; ensuring our patients are able to receive an uninterrupted quality supply of their necessary prescriptions on time

  • Support a variety of capital and expense projects ranging from project management, scope development, alternatives evaluation, engineering design and calculations, funding support, schedule support, construction, oversight, startup, commissioning, qualifications, and validations; including direction of other technical and contract personnel

  • Support and/or lead identification and implementation of near and long term changes including; analyzing and solving process performance problems, root cause analysis, and ownership/sponsorship of corrective and preventative actions

  • Develop solutions to complex problems, which may require highly innovative and ingenious approaches

  • Understand and provide technical support for all site utility systems including natural gas systems, water pretreatment systems, drain systems, water for injection systems, plant & clean steam systems, cooling water system, lab vacuum air systems, air systems, and bulk gas/chemical systems

  • Perform process monitoring to understand operating costs and equipment/system reliability and efficiency as well as justify projects

  • Conduct engineering evaluations during discrepancy investigations and corrective actions

  • Develop engineering documents such as P&IDs, PFDs, equipment specifications and scope changes.

  • Site energy and/or water manager

  • This description is not intended to be all-inclusive

 

Qualifications

  • B.S. in Chemical Engineering, Mechanical Engineering or equivalent

  • 5 – 7 years of relevant experience.

  • Willing to develop strong understanding of GMP clean water systems including reverse-osmosis water, water-for-injection, and pure steam systems and other non-GMP utilities.

  • Must understand and use basic engineering techniques and principles and the ability to apply that knowledge

  • Must be able to function in a team environment, interacting with various functional groups, as well as in a self-managed environment

  • Ability to communicate information accurately and concisely, both verbally and in writing, to a diverse audience, in particular Manufacturing, Quality, SHE, Engineering Services, Facility Services, and Corporate Engineering

  • Highly organized and ability to multi-task, handling highly complex and technical tasks simultaneously

  • Ability to perform to systems assigned by the manager

  • Ability to produce high quality and accurate work in a timely manner

  • Ability to develop into project engineering/management with associate processes and documentation

  • Appreciation of industry standards, codes and construction practices is desirable

  • cGMP and Quality experience is a plus

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