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Senior Manager Manufacturing Systems Engineering - Automation at Amgen's newest and most advanced drug substance manufacturing plant in Holly Springs, North Carolina. The role involves leading a team of Automation Engineers, providing technical and administrative leadership, and ensuring the automation team delivers services for Drug Substance manufacturing.
Job Responsibility:
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)
Meeting key performance metrics, leading and technically developing reports, and ensuring all targets and turning points are completed on time
Ensuring the automation team applies the Corporate Automation Business Processes and drivers to deliver the automation services to the organization
Lead a team of Automation Engineers and serve as the main point of contact for automation function for ANC1 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, 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 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
Work with diverse groups (Manufacturing, Quality, PD, Automation, Technology, EHSS, Global Engineering) and drive new business processes to ensure continuous and sustained improvements
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 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 meetings – Manufacturing area & plant WCTs, Automation WCT, Automation leadership WCT, etc.
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 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
Additionally: in addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
Nice to have:
Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
Experience with Emerson DeltaV DCS system, Siemens DesigoCC, 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
What we offer:
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