Manager, Automation & Calibration Engineering

With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry!<br><br>The Manager, Automation & Calibration Engineering is responsible to provide leadership and management of design, development, and implementation of automation and calibration systems including engineering, start-up, commissioning and qualification of process control systems to support Dispensary, Compounding, Packaging, Warehouse, and QC lab operations for the Fougera manufacturing facilities. Duties include engineering staff management, tracking financial success, providing fit-for-purpose automation systems, planning for system maintenance, and ensuring compliance with Novartis quality requirements. Create the roadmap for the Fougera Automation Systems including determination and specification of system architecture, site goals, and compliance strategies relative to automation; act as subject matter expert in automation (PLCs, HMIs, Data Historian, SCADA, MES, etc.); and lead automation engineers & technicians responsible for supervising the design, start-up, and maintenance of the automation systems for the facilities.<br>• Ensure all company and site Engineering policies and procedures are adhered to.<br>• Ensure all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards.<br>• Manage, lead, monitor, motivate, and mentor the Automation & Calibration Engineering Department Staff.<br>• Develop strategic objectives for department and implements according to pre-established plans.<br>• Manage automation & calibration engineering staff, vendors, and engineering/commissioning contract staff<br>• Implement and coordinate activities associated with staffing, training, purchasing, budgeting, compliance, reporting and quality of service<br>• Through automation engineering and technical support team, provide support for end users through life-cycle document reviews, training, and turnover of systems to operations<br>• Manage automation engineering staff project performance from inception thru completion relative to automation/control system fabrication, installation, validation, and in accordance with good documentation practices<br>• Ensure compliance with testing of all levels of software in the life cycle of a project and the preparation of functional specification documentation and software design specifications<br>• Initiate automation and control projects based on compliance, corporate directives, safety, efficiency, and/or improvements, keeping current within guidelines of cGMP, FDA, OSHA, NFPA or other governmental agencies<br>• Responsible for budgeting, monitoring, forecasting, and reporting costs and scheduling (preferred).<br>• Research new technologies for the on-going and continuous operation of all Process, Packaging, and Facility automation and controls (preferred).<br>• May require travel to industry shows and expositions, or to vendors to perform Vendor Evaluations, Design Reviews, and Factory Acceptance Testing (FAT).<br>• Perform any other activities as directed by the Director of Engineering.<br>• Support and Meet Departmental, Plant and Corporate HS&E goals. Work in a safe and efficient manner.<br>• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). <br>• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.<br><br>Position includes working in all areas of two facilities, including office areas, production, warehousing, laboratory, and utility rooms. Climbing ladders, stairs, working/climbing through construction areas, and some lifting to facilitate project requirements is required.<br><br>While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.<br><br>[#video#https://youtu.be/HUSA096Nn_E{#400,300#}#/video#]