Senior Manager Manufacturing Systems Engineering - Automation (Multiple Positions)

• Senior Manager Automation Systems: Responsible for leading and supporting Building Automation Systems (BAS/QBAS), Rockwell PLC platforms, Upstream Process Control Systems (PCS), and Clean Utility PCS.
• Senior Manager Manufacturing & Project Delivery: Responsible for New Product Introduction (NPI) delivery, project implementation, manufacturing shift floor support, and Downstream Process Control Systems (PCS).

Indicate area of interest and relevant experience as it aligns with one or both of these leadership opportunities., Letsdo this.Letschange 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.

We are hiring two Senior Manager, Manufacturing Systems Engineering positions, each with a distinct area of focus, * High school diploma / GED and 12 years of Engineering and/or ProjectManagement 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 2years experiencedirectly managing people and/or leadership experience leading teams, projects, programs, or directing the allocationorresources. 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

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

At Amgen, if you feel likeyourepart of something bigger,itsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980,wevehelped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team,youllhelp make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities thatliewithin them,youllthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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., We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together-to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.