Senior Manufacturing Systems Engineer: Automation - BAS / PLC

BioSpace; Holly Springs (NC); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Flexible work models (remote/hybrid)

Job summary

Amgen in North Carolina is seeking a Senior Manufacturing Systems Engineer: Automation - BAS/PLC to provide automation technical leadership to a team of automation engineers supporting GMP Drug Substance Plant Operations.

You will collaborate with the capital project team to deliver robust BAS and PLC-based systems, lead FAT, ensure validation, and drive continuous improvement for facilities.

Qualifications

• High School Diploma / GED with 10 years engineering experience, or an associate's degree with 8+ years.
• Bachelor's degree with 4+ years, or Master's with 2+ years; Doctorate is acceptable.
• Demonstrated knowledge of building automation, PLCs, GMP/GAMP compliance.

Responsibilities

• Site design, construction, start-up, and readiness for BAS and PLC systems.
• Develop and maintain engineering documentation; support validation in a GxP environment.
• Lead FAT tests and ensure control strategy and software meet Amgen requirements.
• Provide day-to-day operational support including on-call for BAS and PLC systems.
• Drive continuous improvement for utilities and building equipment.

Skills

Leadership

Technical writing

Communication

Cross-functional teamwork

GAMP GMP knowledge

PLC programming

Education

Electrical Engineering degree

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped 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, youll help 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 that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Manufacturing Systems Engineer: Automation - BAS / PLC

Live

What You Will Do

Lets do this. Lets change the world. As a Senior Manufacturing Systems Engineer, you will provideautomationtechnical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP DrugSubstancePlant Operations.

In this vital roleas a member of the Facilities & Engineering (F&E) Automation teamyou 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 Amgens specifications, incorporates the latest technology and meets safety requirements.
  
  
  • Lead vendors FAT (for the automation testing) and ensure that control strategy and software code meet Amgens 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


• Associates Degree and 8 years of Engineering experience OR


• Bachelors Degree and 4 years of Engineering experience OR


• Masters 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, well 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

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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. 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.