Manufacturing Systems Engineer: Automation
Amgen
Summary
As a Manufacturing Systems Engineer, you will work with 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.
Job description
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.
Basic Qualifications
- 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
Preferred Qualifications
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
- 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.
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
- Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
- 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
Benefits
- Retirement and savings plan
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus
- Stock-based long-term incentives
- Paid time-off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.