Senior Manager Manufacturing Systems Engineering - Automation

Amgen • Holly Springs, NC

2d • Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a leader in biotech, focused on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. This role is part of Amgen's newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility, which combines disposable technologies with traditional equipment and integrates industry 4.0 capabilities and sustainability innovations. The Senior Manager will provide technical and administrative leadership to a group of Automation Engineers responsible for administering and maintaining automation systems for Drug Substance manufacturing at Amgen North Carolina (ANC). This includes meeting key performance metrics, leading and developing reports, ensuring targets are met, and applying Corporate Automation Business Processes. The role is within the Facilities & Engineering (F&E) group and reports to the Director of Engineering at Amgen North Carolina.

Requirements

• High school diploma / GED and 12 years of Engineering and/or Project Management experience OR Associate’s degree and 10 years of Engineering and/or Project Management experience OR Bachelor’s degree and 8 years of Engineering and/or Project Management experience OR Master’s degree and 6 years of Engineering and/or Project Management experience OR Doctorate degree and 2 years of Engineering and/or Project Management experience
• Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Managerial experience may run concurrently with the required technical experience.

Nice To Haves

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
• Experience with Emerson DeltaV DCS 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

Responsibilities

• Lead a team of Automation Engineers and serve as the main point of contact for the automation function for ANC 1 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.
• Provide 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.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior