Amgen Inc

Senior Manager Manufacturing Systems Engineering - Automation

Amgen Inc • $163K — $220K *
Holly Springs, NC 27540In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or related field with 8+ years of relevant experience OR higher advanced degree with commensurate experience.
  • 2+ years of management or direct leadership experience, ideally within engineering or project management.
  • Strong background with Emerson DeltaV, Allen Bradley PLCs, and Siemens Desigo CC systems.
  • Experience in automation of GMP biopharmaceutical equipment and systems.
  • Familiarity with compliance regulations such as 21 CFR Part 11 and GAMP.

Responsibilities

  • Lead a team of Automation Engineers in managing automation systems for Drug Substance manufacturing.
  • Develop and oversee the automation and process control strategy for manufacturing.
  • Serve as a senior advisor to management, ensuring alignment with organizational development strategies.
  • Provide day-to-day operational support while promoting team productivity and resource efficiency.
  • Collaborate with internal teams to execute capital projects and support plant operations.

Benefits

  • Comprehensive employee benefits package including health, dental, and vision coverage.
  • Generous retirement and savings plan with company contributions.
  • Flexible work models, including potential remote work arrangements.
  • Award-winning time-off plans and company-wide shutdowns twice a year.
  • Discretionary annual bonus program and stock-based long-term incentives.
Full Job Description
Career Category
Engineering
Job Description

Senior Manager Manufacturing Systems Engineering - Automation

What You Will Do

Let's do this. Let's change the world. In this role The Senior Manager is 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 1 manufacturing. Systems including Allen Bradley PLCs, Siemens Desigo CC for building automation, and Emerson DeltaV for 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.


  • Provid 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. 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.


What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The engineering management professional we seek will possess these 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 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


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.

careers.amgen.com

#AmgenNorthCarolina

Salary Range
163,288.40USD -220,919.60 USD

About Amgen Inc

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases. The company is values-based and deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious diseases. They offer products for treating illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.

Amgen Inc Careers

Join the dynamic team at Amgen Inc, a biotechnology pioneer dedicated to discovering, developing, and delivering innovative human therapeutics. At Amgen, we offer more than just job opportunities; we invite you to be part of a culture of leadership, diversity, and innovation.

Work You’ll Do

At Amgen Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that brings real solutions to patients worldwide. Our commitment to your career growth is evident in our professional development and leadership training programs designed to nurture your potential.

Innovate and Lead

Amgen Inc stands at the forefront of biotech innovation. Our team is constantly pushing the boundaries of science and technology. By joining us, you will contribute to a legacy of medical breakthroughs that improve the lives of millions.

Be Part of a Great Team

Amgen’s inclusive culture and commitment to diversity are integral to our success. We believe in empowering our employees with the skills and networking opportunities they need to thrive. Our team’s collaboration is the key to developing groundbreaking solutions.

Future-Proof Your Career

Amgen Inc offers a variety of career paths, from research and development to marketing and sales, providing near-limitless opportunities for advancement. Whether you are looking for a full-time position, an internship, or a leadership role, Amgen has a place for you. Our robust benefits package supports the well-being of our employees and their families, contributing to a fulfilling work-life balance.

Explore Job Opportunities

Discover the impact you can make with a career at Amgen Inc. We are hiring creative, curious, and motivated individuals ready to face challenges head-on. Explore our open positions that match your skills and interests.

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Interview and Resume Tips

Prepare for your future with Amgen Inc by utilizing our resources designed to enhance your interview skills and polish your resume. Our hiring process is designed to identify and attract professionals who are driven to make a difference.

Amgen Inc—Where Careers Grow

At Amgen Inc, we are committed to turning innovative science into value for patients. If you are passionate about joining a team that makes a difference, search Amgen jobs today and take the first step towards a fulfilling career.

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Join us at Amgen Inc, where your career can flourish in an environment of innovation, leadership, and growth.
Learn more about Amgen Inc
Size
24,200 employees
Market Cap
$141.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7.2 billion
Founded
1980
5 Year Trend
+2.5%
Revenue
$25.4 billion
NASDAQ
AMGN
* Ladders Estimates

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