California, United States of America
This position is for Sr. Automation Engineer reporting into the CCP2 (Cell Culture Plant 2) Process Automation CSE
(Control System Engineering) group within the Manufacturing Sciences and Technology (MSAT) department.
Process Automation CSE group is responsible for maintaining existing MCS that comprises of POMSNet and Experion
PKS system in compliance state as well as implementing new automation solutions. Major milestones of CCP2
Automation road map include upgrading existing Honeywell MCS, design and build new DeltaV based solution and
migration of standalone PLC based systems to SCADA systems.
The Sr. Engineer will provide automation support on capital projects and implement changes/ improvements on automation
systems in bio-pharmaceutical manufacturing operations as part of the Vacaville manufacturing plant. Major areas in
CCP2 plant includes Media preparation, Fermentation, Centrifugation, Column chromatography, Buffer preparation, TFF
operations, and filtration/freeze operations.
The Sr. Engineer will be responsible for working with vendor on design, build, implementation and validation of DeltaV
based automation system. He/she will be part of a team that provides 24/7 technical support for make, asses, and release
activities and capital project execution. The candidate must be a self-starter who can independently drive projects and
day-to-day work tasks to completion according to schedule and must be able to work well with others as a team member
in an informal results oriented environment.
The candidate will provide technical leadership and support of the CCP2 Distributed Control System includes but is not
limited to the following:
- Automation design and support to the manufacturing DCS using the following applications as well as providing leadership
in the implementation of automation changes.
- DeltaV, DeltaV Batch and Syncade
- Honeywell MCS system (Experion PKS and Total Plant Batch applications) and POMS is a PLUS
- Troubleshooting of process, equipment, and system malfunctions or failures involving the DCS/MCS system, including
after hours on-call support. Initiate immediate corrective or preventative actions to ensure continued compliant operation
including emergency change records as needed.
- Provide technical assessments and evaluations for discrepancies that occur during manufacturing operations, as well as
provide technical input for investigation and/or developing and implementing corrective action plans.
- Redline automation functional specifications for automation lead review/approval, troubleshoot the DCS/MCS system and
software, prepare automation change record forms and perform off-line and on-line coding and testing.
- Support and lead Automation projects with activities such as detailed design, design review, implementation, testing/
debug, and troubleshooting and project management.
- Work with Manufacturing, Quality, Facilities, and MSAT departments to implement continuous improvement changes as
well as capital projects ranging from product technology transfers, to DCS migrations.
- Clearly communicate across functional departments at various levels to drive efficient issue resolution and change
- B.S. or M.S. in Engineering such as Automation, Chemical, Electrical, or equivalent preferred.
- 8+ years’ work experience as a practicing professional in cGMP biopharmaceutical production. Work experience
specific to automation design, implementation and/or support involving instrumentation and control systems, preferably in
the biopharmaceutical or pharmaceutical
- Strong experience in design, build and installation of Emerson’s DeltaV, DeltaV Batch
- Experience in Syncade MES and OSI PI is a PLUS
- Experience with programming languages and applications such as C, C# Visual Basic and Microsoft SQL Server is a
- Thorough understanding of Good Manufacturing Practices (GMPs) as they apply to bioprocess manufacturing.
- Thorough understanding of Good Automated Manufacturing Practice (GAMP) as it applies to automation design,
implementation, and testing.
- Experience of working with systems integrator in design and build of the system is a plus.
- Demonstrated training ability, communication skills, and initiative. Strong written and verbal communication,
interpersonal, leadership, and team skills.
- Must be flexible for after-hours call support rotation and floor support of 24/7 operations.
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.
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