Senior Manufacturing Systems Engineer Automation Delta V - NC

Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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 process automation systems to operate the new plant.
Site design, construction, start-up, and operational readiness
Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy
Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)
Support QA partners in performing computerized systems validation in a GxP environment
Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
Site Operations
Own and drive to completion Change Controls, CAPAs, and Deviations
Lead and support technical root cause analysis, incident investigations, and troubleshooting
Lead and support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility
Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability
Support day-to-day operations including rotational on-call support
Perform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
Additional Qualifications/Responsibilities
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, Computer Science, Chemical Engineering, Biotech Engineering, or related field
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.
Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation 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
Ability for domestic and international travel
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 competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team!
careers.amgen.com
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.
Salary Range
142,955.00 USD - 162,947.00 USD