Systems Analyst I

Responsible for completing scheduled administrative tasks on MES / eBR and Serialized platforms Provide technical support for Manufacturing operation Management systems, MES / eBR and Serialized to engineering, Validation maintenance, Process Automation and process engineers across Manufacturing and Process Development as required  Proactively identify opportunities, anticipates problems and implement solutions with the Process Automation Engineers, Process Engineers, Manufacturing Associates and the Maintenance team as required for business impacting issues Records and investigates issues, performs root cause analysis, escalates to management and other teams as required. Co-ordinates the response with external vendors for issue resolution, upgrades etc. Assist in co-ordination and Manufacturing operation Management related projects. Works with vendors, Engineering project managers and business users to implement systems to the required standards. Liaise and communicate with site users and vendors to ensure Manufacturing operation Management related systems operate to maximum effect, and as per the Site IT Automation Strategy Apply knowledge and support for 21CFR part 11 and God Manufacturing Practices Prepare specifications, protocols, procedures, and other documentation as required. Keep documentation current as per site good documentation and data integrity practices (drawings, specifications, validation documentation etc).  Perform support (with some after hour on-call), change control, and applicable maintenance of above systems. Demonstrates the ability to operate in a culture of efficiency, helpfulness, innovation, continuous improvement, enthusiasm, reliable & consistent delivery, integrity, partnership, and collaboration, locally and globally Responsible for completing scheduled administrative tasks on MES / eBR and Serialized platforms Provide technical support for Manufacturing operation Management systems, MES / eBR and Serialized to engineering, Validation maintenance, Process Automation and process engineers across Manufacturing and Process Development as required  Proactively identify opportunities, anticipates problems and implement solutions with the Process Automation Engineers, Process Engineers, Manufacturing Associates and the Maintenance team as required for business impacting issues Records and investigates issues, performs root cause analysis, escalates to management and other teams as required. Co-ordinates the response with external vendors for issue resolution, upgrades etc. Assist in co-ordination and Manufacturing operation Management related projects. Works with vendors, Engineering project managers and business users to implement systems to the required standards. Liaise and communicate with site users and vendors to ensure Manufacturing operation Management related systems operate to maximum effect, and as per the Site IT Automation Strategy Apply knowledge and support for 21CFR part 11 and God Manufacturing Practices Prepare specifications, protocols, procedures, and other documentation as required. Keep documentation current as per site good documentation and data integrity practices (drawings, specifications, validation documentation etc).  Perform support (with some after hour on-call), change control, and applicable maintenance of above systems. Demonstrates the ability to operate in a culture of efficiency, helpfulness, innovation, continuous improvement, enthusiasm, reliable & consistent delivery, integrity, partnership, and collaboration, locally and globally Bachelor’s degree preferred (Engineering or Computer Science); or degree in process, with experience on and Manufacturing operation Management systems Demonstrated track record of administration and support of Manufacturing operation Management platforms Previous experience in the biotechnology / pharmaceutical industries and GXP Computerized Systems Excellent analytical problem solver Experience with Electronic Batch Records eBR Experience with Serialized packaging systems and associated vision systems Experience with OSI PI Historian or similar data historian