Senior Manager Manufacturing Systems Engineering

What You Will Do

Let’sdo this.Let’schange the world. In this role The Senior Manageris responsible forproviding technical and administrative leadership to a group of Automation Engineers accountable for administrating andmaintainingautomation systems for Drug Substance manufacturing at AmgenNorth 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 teamappliesthe Corporate Automation Business Processes and drivers to deliver the automation services to theorganization.

As part of the Facilities& Engineering (F&E) group, the Senior Manager will work with the Director of Engineering atAmgenNorth 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 forANC1manufacturing.Systems including Allen Bradley PLCs, SiemensDesigoCCforbuildingautomation, and EmersonDeltaVfor 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.

• Providinput into departmentobjectivesandestablishingstrategic 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.

• Identifyareas 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 budgetforecastand adhere to department budgets and spendforoperational 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 ismaintainedat 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 forproductionBatch records, cleaning, and sterilization systems, including Audit trail and version control.

• Responsible for ensuring that service contracts with all OEMs for systems areestablishedfor 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, andfacilityto provide 24x7 reliable plant automation support.

• Responsible for ensuring that the automation team activelyparticipatesin daily/weeklyWork 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 issolicitedfrom the automation staff and actions are taken tomaintainproper work-life balance.

What We ExpectOfYou

We are all different, yet we all use our unique contributions to serve patients. The engineering management professional weseekwillpossessthese qualifications.

Basic Qualifications:

• 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. 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 EmersonDeltaVDCS system, SiemensDesigoCC, Allen BradleyPLCand 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 usemixing 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

Thrive 

What you can expect of us 

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.  

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:  

• 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, or for field sales representatives, a sales-based incentive plan 

• 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 

Apply now for a career that defies imagination 

Objects in your future are closer than they appear. Join us. 

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.