This position will lead the Automation area of the Engineering and Maintenance Department. Provide direction to the Automation Engineers with technical support and troubleshooting day to day automation issues within a cGMP production environment. This position will play a key role in all stages of the engineering project and equipment lifecycle from conceptual design, detailed design, specification, implementation, commissioning, troubleshooting, and continuous improvement of Automation systems in the production and supporting utility systems.
- Manage the Automation Team in order to assure support to the needs of the supported areas and projects of the site. Develop and/or revise procedures and/or preventive maintenance instructions to organize and align team activities and process with current computer system regulations.
- Responsible for developing and managing area budget.
- Identifies and implements improvement projects to reduce manufacturing costs.
- Support Engineering and Maintenance Director in development, establishment and adherence to long-range Automation goals.
- Diagnose and solve moderate to complex automation problems to support 24/7 manufacturing activities. Uses operational excellence and lean methodology to generate pragmatic, innovative and robust solutions.
- Recommend new technologies and implement modern controls architectures in line with current trends in GMP’s and automation and instrumentation technology.
- Objectively analyze data and align expectations to bring definition to projects that have loosely defined objectives.
- Work across functions and disciplines to collect and analyze data to improve the compliance and efficiency of manufacturing activities.
- Identify and manage Automation projects involving multiple functions and disciplines within the organization.
- Good understanding of industry standards and practices related to controls software design and commissioning.
- Ensure compliance with company policies, Standard Operating Procedures (SOPs) and cGMP requirements.
- Drive and support deviations/investigation related to the Automation area and ensure their timely completion. Support the SME team to establish required CAPAs to eliminate or reduce possibilities of event recurrence. Monitor the timely completion of CAPAs. Generate and monitor KPI metrics to evaluate the compliance of these activities.
- Support in the development and implementation of Automation strategies required for meeting company objectives.
- Other related duties as assigned to meet departmental and Company objectives.
Experience & Education
- Bachelor's Degree in Engineering, Electrical, Controls or Chemical Engineering is preferred, with a minimum of 5 years of broad-based technical management, preferably in a pharmaceutical manufacturing environment. Also, a minimum of 5 years of management experience required for this position.
- Demonstrated positive results in progressive positions of authority, including a record of success in a cGMP pharmaceutical manufacturing environment.
- Minimum 5 years BMS, PLC, SCADA, Manufacturing Databases, instrumentation configuration, programming, and design in a cGMP environment.
- Experience in Project Management of Automated systems.
- Experience with Allen Bradley PLC platforms as well as Siemens BMS systems, SCADA systems, PI Historian, iFix, iHistorian, Industrial Ethernet networks, ControlNet networks.
- Experience with Electronic Batch Records following ISA S88 using Rockwell Automation platform.
- Familiarity with batch and continuous processes within the Pharmaceutical Industry is preferred.
- Knowledge of GAMP 5 preferred
- Experience with S88, ISA standards and Advanced GxP Data Acquisition and reporting.
- Strong organizational and teamwork skills.