Senior Control Systems Engineer

Bayer HealthCare Pharmaceuticals is a leading global specialty pharmaceutical and biotechnology company. With over $3 Billion in protein drug sales, Bayer ranks as the sixth largest biotech company in the world.Emeryville, California is home to one of Bayer's key biomanufacturing operations dedicated to the production of its top-selling drug Betaseron/Betaferon®, a leading therapy for multiple sclerosis. This manufacturing center is the latest addition to Bayer's fast growing biotech operations on the West Coast of the U.S. Along with sites located in neighboring Berkeley and Richmond, Bayer has now developed into the second largest biotech employer in the Bay Area. The company has over 2,200 employees in the Bay Area, dedicated to every aspect of biotechnology- research, development, manufacturing, and commercializationPOSITION DESCRIPTIONThe Senior Controls Engineer is responsible for all control systems in the CMF and PDU, ensuring their reliability and compliance to cGMPs and safety.Lead troubleshooting and mediation activities for control systems problems.Ensure the compliance of control systems to 21 Part 11 including back-up and disaster recovery strategies.Monitor and ensure the efficient operation and reliability of these systems. Identify opportunities for continuous improvement and pursue relevant software and hardware upgrades. Understand and apply preventative maintenance methods to predict and avoid potential equipment failure.Initiate capital projects and support the project stages during design and execution. Coordinate with Manufacturing and Quality groups and collaborate with customers and other support groups to ensure deliverables are provided in a timely manner, within budget and with the expected quality.Commission new equipment and prepare and support subsequent validation activities. Review, update and correct controlled engineering documentation to ensure compliance to GAMP, SOPS and applicable codes and guidelines.Communicate with and present to outside regulatory agencies. Interact with vendors and suppliers. Standardize technical specifications and components.POSITION REQUIREMENTSBS in Engineering.- Thorough knowledge and programming experience in control systems like ALAN BRADLEY andSIEMENS PLCs- Experience with SCADA systems, WINDOWS or DOS based application software for HMI and associated electrical systems- Knowledge of integrated systems and networks- A minimum of 10 years industry experience with at least 5 years in a GMP environment in pharmaceutical/biotech manufacturing.