21 days old

Associate Director Engineering, Automation

Roche
Vacaville, CA

This Associate Director, Automation role has responsibility for leading the Automation group for one of the two plants at the Vacaville Drug Substance Manufacturing site (Cell Culture Plant 2 or CCP2).   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 Automation groupâs activities include the design, development, testing, and deployment of automation hardware and software associated with optimizing operational performance and compliance for the existing product as well as âœRight First Timeâ technology transfers of new products into CCP2 under tight timelines while meeting rigorous quality and compliance standards. 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. The CCP2 manufacturing related computer/automation/process control systems include, but are not limited to the Distributed Control Systems (DCS), integrated planning/scheduling sand 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 CCP2 Automation leader sets 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. In addition, the leader will help to establish and adhere to network configuration standards and practices while ensuring lean, efficient work processes are deployed. Additionally, the Associate Director will collaborate to ensure CCP2 automation/process control alignment with the CCP1 process automation teams as well as other automation groups across the Roche Pharma Technical Operations network.


Responsibilities  

  • Provide direction and oversight for all activities for the CCP2 Automation 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 strategic and tactical leadership in the stabilization of the CCP2 Manufacturing Process Control systems in alignment with the Roche/Genentech Automation network.  
  • Provide leadership and guidance to subordinate staff including performance managementcareer development and succession plans. 
  • Ensure the global compliance of the CCP2 process automation systems, including direct interaction with Health Authority inspections.    
  • Ensure timely completion of Automation projects, including CAPAâs according to established timelines and schedules. 
  • Create capacity models. 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. 
  • Prepare regular reports regarding automation engineering activities, schedule, resource needs, budget updates and other pertinent information to senior site and network management.  
  • Set policies and procedures for contract firms engaged in the support, design and installation of manufacturing related computerized systems. 
  • Provide technical leadership and oversight for the start-up and troubleshooting of process equipment and critical automation systems 
  • Provide input, review and approval for the policies and procedures associated with the validation of process automation systems and manufacturing related computerized systems at the Vacaville site. 
  • Provide Subject Matter Experts (SMEâs) to support Health Authority and Internal Inspections, including playbook development and communication materials.

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Requirements:  
 

Education and Experience  

  • Minimum of a BS in an engineering discipline or life science with relevant work experience. 6+ years of managerial experience and 12+ years of experience in the pharmaceutical or biotechnology industry. 
  • Experience with engineering, design and implementation of complex automation systems in a process environment required. Demonstrated strong technical and people leadershipcommunication and teamwork skills also required.  
  • Experience in a related discipline outside of Engineering, preferably manufacturing.  Experience leading large capital projects is also desirable. 
      

Knowledge, skills and abilities  

  • Understanding the principles of Knowledge of current automation engineering approaches and construction techniques used in Biotechnology/Pharmaceutical manufacturing facilities and Health Authority expectations for validation of equipment, instrumentation and computer systems.   
  • Prior experience with translating complex P&IDs into Process Descriptions and subsequent design documents (Functional Requirement Specifications, Detailed Design Specifications). 
  • Working knowledge of ISA S88 batch standards as applied to Biotechnology/Pharmaceutical manufacturing projects.  
  • Thorough knowledge of GAMP standards as they related to biopharmaceutical process operation and process control, process equipment and supporting utility systems, especially those related to sanitary and sterile operations; cGMP guidelines, and extensive experience in equipment start-up and validation. Validation experience related to equipment, clean utility and process systems, including requirements for documentation and testing.  
  • Working knowledge of Emerson Syncade and Delta-V is preferred.
  • Prior experience in engineering principles applied to control and computer system design.
Posted: 2018-12-25 Expires: 2019-01-24

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Associate Director Engineering, Automation

Roche
Vacaville, CA

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