Senior Manager Manufacturing Systems Engineering - Automation

About the role

The Senior Manager is responsible for providing technical and administrative leadership to a group of Automation Engineers accountable for administering and maintaining automation systems for Drug Substance manufacturing at Amgen North Carolina (ANC).

Responsibilities

• Lead a team of Automation Engineers and serve as the main point of contact for automation function for ANC1 manufacturing systems including Allen Bradley PLCs, Siemens Desigo CC for building automation, and Emerson DeltaV for process control.
• Define, drive, and deliver the automation and process control strategy within Drug substance manufacturing.
• Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy.
• Strategic and tactical management and leadership in providing 24x7 day-to-day operational support, mentoring, staff development, team productivity, and efficient use of available resources.
• Develop support structures with internal/multi-functional teams for capital projects, plant support, and Amgen network-level initiatives' execution.
• Provide input into department objectives and establish strategic direction within the Drug Substance Network for the F&E automation team.
• Maintain and improve capabilities and automation systems reliability in partnership with F&E and plant leadership, and other technical staff in the network, focusing on Maintenance Excellence systems failures and recurrence avoidance.
• Work with diverse groups (Manufacturing, Quality, PD, Automation, Technology, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements. Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical/business proposals.
• Identify areas of potential improvement, conduct analysis, recommend solutions, sponsor improvement projects, and implement.
• Ensure site readiness and compliance for internal audits, external agency audits, and partner audits.
• Ensure the safety of all personnel during plant operations and engineering activities.
• Develop expense budget forecast and adhere to department budgets and spend for operational and capital expenses, holding 100% accountability.
• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.
• Ensure Amgen Enterprise cyber resiliency compliance is maintained at 100%.
• Ensure the right processes/systems are in place to capture 100% quality compliance for the right-first-time (RFT) delivery of automation solutions.
• Ensure that reporting functionality is incorporated for all unit operations for production Batch records, cleaning, and sterilization systems, including Audit trail and version control.
• Responsible for ensuring that service contracts with all OEMs for systems are established for service and support needs, including service banked hours for specialized support needs.
• Ensure that all automation staff are adequately trained and follow all GMP standards and procedures by managing the team's internal and external training needs.
• Ensure the automation staff are fully aware and confident to work on all automation systems, process equipment, and facility to provide 24x7 reliable plant automation support.
• Responsible for ensuring that the automation team actively participates in daily/weekly Work Center Team (WCT) meetings Manufacturing area & plant WCTs, Automation WCT, Automation leadership WCT, etc. to address day-to-day topics and discuss issues with multi-functional teams to resolve.
• Responsible for ensuring the automation team provides the required support to implement expense, department capital, construction, and GLAM-DTI projects.
• Provide active leadership such that proactive feedback is solicited from the automation staff and actions are taken to maintain proper work-life balance.

Requirements

• High school diploma/GED and 12 years of Engineering and/or Project Management experience OR Associates degree and 10 years of Engineering and/or Project Management experience OR Bachelors degree and 8 years of Engineering and/or Project Management experience OR Masters degree and 6 years of Engineering and/or Project Management experience OR Doctorate degree and 2 years of Engineering and/or Project Management experience
• Additionally: In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of direct experience managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
• Experience with Emerson DeltaV DC S system, Siemens Desigo CC, Allen Bradley PLC and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies
• Direct knowledge of automation system design
• Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
• Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
• Experience in integrating various OEM automation software
• Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.
• Fieldbus, and Profibus technologies
• Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95
• Self-directed team player able to work cross-functionally
• Strong leadership, technical writing, and communication skills