Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch 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.

Senior Manufacturing Systems Engineer: Automation - BAS / PLC

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What you will do

Let’s do this. Let’s change the world.  As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. 

In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust building automation systems (BAS) and PLC based process and utility skid equipment to operate the new plant. 

Job responsibilities include:

• Site design, construction, start-up, and operational readiness:

  • Collaborate with key stakeholders to understand key process requirements and synthesize feedback from clients, customers or end-users to develop the best automation solutions using Amgen standard automation platform for building automation systems and process and utility skid equipment.

  • Develop and maintain engineering and maintenance documentation and associated procedures for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment.  Maintain Data Integrity Assessments with the current Amgen and industry standards.

  • Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.

  • Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy for the building automation systems and process and utility skid equipment in support of the project delivery.

  • Work with platform leads to ensure standalone PLC based systems are designed with the proper network connectivity to enable centralized monitoring and alarming.

  • Support design phases to ensure equipment aligns with Amgen’s specifications, incorporates the latest technology and meets safety requirements.

  • Lead vendor’s FAT (for the automation testing) and ensure that control strategy and software code meet Amgen’s requirements. Emphasize on understand the benefits of a complete and successful FAT will be a contributive factor to successful and on time project delivery.

  • Understand the manufacturing operation and ensure the control strategy aligns with existing manufacturing operations to facilitate release and operation of equipment, especially applicable for retrofit type of projects adding to an existing control system.

• Site Operations:

  • Act as system owner for building automation system and standalone PLC based systems responsible for System Administration, maintenance procedures and job plans, spare parts and engineering documentation.

  • Responsible for owning and driving to completion Change Controls, CAPAs, and Deviations as applicable to the assigned automation system to ensure reliability and compliance.

  • Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.  

  • Drive continuous improvement for utility and building equipment systems to improve operational workflows, safety, reliability, efficiency, and sustainability.

  • Lead/support technical root cause analysis, incident investigations, and troubleshooting on utilities and building automation systems.

  • Provide day-to-day Operational Support including: rotational on call operational Support for building automation systems and process and utility skid equipment.

  • Perform and maintain data integrity assessments in accordance with the current Amgen Global Standard procedures and applicable standards.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications.

Basic Qualifications:

• High School Diploma / GED and 10 years of Engineering experience OR

• Associate’s Degree and 8 years of Engineering experience OR

• Bachelor’s Degree and 4 years of Engineering experience OR

• Master’s Degree and 2 years of Engineering experience OR

• Doctorate Degree

Preferred Qualifications:

• Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related field. 

• Direct knowledge of BMS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software.  

• Experience with building automation systems and process and utility skid equipment, and direct knowledge of integrating various OEM automation software and field instrumentation technologies.

• Knowledgeable of industry standards such as 21 CFR Part 11, ASTM 2500, S95, GAMP 5, and GDP.

• Experience in programming, design, installation and lifecycle management of building automation controls, PLC and field device/instrumentation 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, and S95.

• The ideal individual must be a self-directed team player able to work cross-functionally.

• Strong leadership, technical writing, and communication/presentation skills. 

• Ability for domestic/international travel as needed.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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

• Flexible work models, including remote and hybrid work arrangements, where possible

for a career that defies imagination

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

careers.amgen.com

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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