Senior Manager-Automation Engineering (Manufacturing Systems and Utilities)

at  Amgen

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon-neutral company by 2027.
Senior Manager-Automation Engineering (Manufacturing Systems and Utilities)

BASIC QUALIFICATIONS:

• High school diploma / GED and 12 years of Engineering experience. AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Associate degree and 10 years of Engineering experience OR
• Bachelor’s degree and 8 years of Engineering experience OR
• Master’s degree and 6 years of Engineering experience OR
• Doctorate degree and 2 years of Engineering experience

PREFERRED QUALIFICATIONS:

• 10+ years of relevant work experience in Life Science with a major focus on Process control and automation systems.

Let’s do this. Let’s change the world. In this vital role you will be responsible for providing technical and administrative leadership to a group of Automation Engineers accountable for administrating and maintaining automation systems for Drug Substance manufacturing at Amgen North Carolina (ANC). Responsibilities include meeting key performance metrics, leading and technically developing reports, and ensuring all targets and turning points are completed on time. The Sr. Manager also ensures that the automation team applies the Corporate Automation Business Processes and drivers to deliver the automation services to the organization.

As part of the Facilities& Engineering (F&E) group, the Senior Manager will work with the Director of Engineering at Amgen North Carolina. This role is expected to provide leadership as follows:

• Lead a team of Automation Engineers and serve as the main point of contact for automation function for ANC manufacturing.
• 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 and capital project 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.
• Providing input into department objectives and establishing 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.
• Develop the scope and life cycle upgrade plan in partnership with OEM, Manufacturing, DTI, and GLAM DTI Lead.
• Work with diverse groups (Manufacturing, Quality, PD, Automation, IS, 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.
• Responsible for Staff Management as it relates to on-site and remote work through Automation on-call support planning, execution and report out of the summary.
• Ensure Amgen Enterprise cyber resiliency compliance is maintained at 100%.
• Accountable for reviewing every unit operation, cleaning & sterilization system to ensure that the operational functionalities are configured correctly in the automation systems as per the user requirements for robustness.
• Develop and maintain Preventive maintenance schedule for all automation assets.
• Lead Spare parts Inventory assessment, Maximo asset allocation, and associated spare parts inventory management for all manufacturing systems, including plant central utilities.
• 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 leading 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.