Manufacturing Systems Engineer: Automation - Delta V

Amgen • Holly Springs, NC

9d

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a leader in biotechnology, focused on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. This role is part of Amgen's newest and most advanced drug substance manufacturing plant, the FleX Batch facility, which combines disposable technologies with traditional stainless-steel equipment for operational flexibility. The facility integrates industry 4.0 capabilities and sustainability innovations, aiming for carbon neutrality by 2027. As a Manufacturing Systems Engineer, you will be part of the Facilities & Engineering (F&E) Automation team, responsible for building and maintaining automation systems and platforms supporting GMP Drug Substance Plant Operations. You will collaborate with the capital project team to deliver robust process automation systems for the new plant.

Requirements

• High School Diploma / GED and 8 years of Engineering experience OR Associate’s Degree and 6 years of Engineering experience OR Bachelor’s Degree and 2 years of Engineering experience OR Master’s Degree
• Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software.
• Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies.
• 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 technical writing and communication skills.

Nice To Haves

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

Responsibilities

• Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
• 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.
• Provide clear documentation for delivered solutions and processes.
• 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.
• Support process automation systems 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.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
• Own and drive to completion Change Controls, CAPAs, and Deviations.
• Support technical root cause analysis, incident investigations, and troubleshooting.
• 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.
• Prepare/review Standard Operating Procedures (SOP) and cGMP documents.
• Be constantly curious and feed your passion and interests in groundbreaking technology.
• Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.

Benefits

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED