California, United States of America
Manager/Sr. Manager - CSE The Manager/Sr. Manager – CSE (Control Systems Engineering), CCP2 has responsibility for leading the CSE group within the MSAT –Automation CCP2 department at the Vacaville Drug Substance Manufacturing site. This group is responsible for designing, implementing, and maintaining the manufacturing related automation, process control, and supporting Information Technology (IT) systems for a large, highly automated drug substance manufacturing that is licensed for multiple products. The CCP2 CSE group’s activities include the design, development, testing, and deployment of automation solution associated with optimizing operational performance and compliance for the existing product as well as “Right First Time” technology transfers of new products into CCP2 under tight timelines while meeting rigorous quality and compliance standards. The CCP2 manufacturing related computer/automation/process control systems include, but are not limited to the Distributed Control Systems (DCSs), integrated planning/scheduling and batch management systems, batch and continuous historian, and process automation interfaces with LIMS, TRACKWISE, SAP, the internally built Review by Exception system for automated batch record review and other business systems. The main focus areas in CCP2 is maintaining the capability and compliance of the licensed products while adding additional products to the same facility using the same process automation systems and design, build, and implement new automation solution that is aligned with global drug substance sites. Manager/Sr. Manager - CSE works with Associate Director –Automation in setting the strategic direction for the 10-year roadmap of CCP2 automation improvements including the simplification of the overall systems and the upgrade/replacement cycle for obsolete software and hardware. Responsibilities - Provide direction and oversight for all activities for the CCP2 CSE group and define policies to ensure the CCP2 Automation priorities, strategies and objectives align with the overall Roche and site priorities, strategies and objectives. - Provide technical oversight for installing upgrades required for stabilization of the CCP2 Manufacturing Process Control systems. - Provide technical oversight to design, build, and implement automation solution that is aligned with global drug substance sites. - Focus on developing people: - Identify technical skill set gaps within CSE group, develop technical acumen within the team, and hire people to address the gaps. - Provide leadership and guidance to subordinate staff including performance management, career development and succession plans - Ensure the global compliance of the CCP2 process automation systems, including direct interaction with Health Authority inspections. - Ensures lean, efficient work processes are deployed. - Development and execution of resourcing and staffing strategies to ensure delivery of activities and scopes of work from various internal groups and external consultants and/or contractors.
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