Mfg Systems Engineer (DeltaV)
Amgen
Summary
Amgen is seeking an Automation Engineer, internally known as a Manufacturing Systems Engineer, in our state-of-the-art Rhode Island facility to join the Automation Engineering team and who will report to the Mfg Systems Engineering Manager. In this vital role you will support complex and challenging process automation initiatives that require understanding of analytical problem-solving techniques, project management, lifecycle management and Operational Excellence. Additionally, the person is responsible for providing project leadership and daily operational support to the Automation Engineering team at the Amgen Rhode Island site.
Job description
Key Responsibilities Include:
- Provides technical support to commercial manufacturing, specific to process control, automation infrastructure, and process systems
- Works closely with multiple teams, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to manage a diverse portfolio of projects
- Leads and supports technical root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems mainly rooted in DeltaV
- Supports new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs
- Devises new approaches to complex problems through adaptations and modifications of standard automation technical principles
- Develop, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity
- Communicates with multiple levels within the organization, highlighting issues and proposing solutions
- Supports capital project design review, commissioning, and qualification
- Applies automation engineering principles in the design, specification, construction, startup, and validation of process and GMP utilities equipment and systems for an array of projects of significant scope and complexity
- Provides technical support and issue resolution 24x7 on-call support of Automation systems on a rotational based frequency
- Applies experience and knowledge of industry best practices and tools to attain an innovative organization
Basic Qualifications:
- High school diploma / GED and 8 years of automation and/or engineering experience OR
- Associate’s degree and 6 years of automation and/or engineering experience OR
- Bachelor’s degree and 2 years of automation and/or engineering experience OR
- Master’s degree
Preferred Qualifications:
- Bachelor’s Degree related technical field
- 3+ years’ experience in Process Automation Engineering in a manufacturing support environment with at least 1+ year experience in the Pharmaceutical or Biotechnology industries
- 3+ years’ combined experience with the following product platforms: Emerson DeltaV DCS systems
- Familiarity with industry standards for batch control systems, software development life cycle methodologies, S88, 21 CFR Part 11, Validation, and GAMP
- Strong control system automation background. Design, installation, programming and validation of automated processes
- Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services and non-GMP Utilities preferred
- Experience with Tech Transfer, Process Design, and Commissioning
- Experience with validation and change control methodology
Requirements
- High school diploma / GED and 8 years of automation and/or engineering experience OR Associate’s degree and 6 years of automation and/or engineering experience OR Bachelor’s degree and 2 years of automation and/or engineering experience OR Master’s degree
- Bachelor’s Degree related technical field
- 3+ years’ experience in Process Automation Engineering in a manufacturing support environment with at least 1+ year experience in the Pharmaceutical or Biotechnology industries
- 3+ years’ combined experience with the following product platforms: Emerson DeltaV DCS systems
- Familiarity with industry standards for batch control systems, software development life cycle methodologies, S88, 21 CFR Part 11, Validation, and GAMP
- Strong control system automation background. Design, installation, programming and validation of automated processes
- Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services and non-GMP Utilities preferred
- Experience with Tech Transfer, Process Design, and Commissioning
- Experience with validation and change control methodology
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life and Disability Insurance
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-based Long-term Incentives
- Paid Time Off
- Flexible Work Models
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.