Amgen · 7 hours ago
Senior Manufacturing Systems Engineer: Automation - PLC
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
4+ years expAmgen is a leading biotech company dedicated to serving patients with serious illnesses. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a team responsible for building and maintaining automation systems in the GMP Drug Substance Plant Operations.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Develop and maintain automation solutions utilizing various PLC's such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system
Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLC’s and interface hardware
Lead and support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including power distribution, grounding requirements, I/O assignments, etc
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
Lead in continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems
Collaborate with business partners to understand how standalone systems can improve workflow and productivity. Synthesize requirements from clients, customers, or end-users to develop the best automation solutions
Provide clear documentation 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
Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units
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
Lead and support technical root cause analysis, incident investigations, and troubleshooting on standalone systems
Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable
Lead Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Standalone Systems, Preventative and Corrective Maintenance, and Automation System spare parts management
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
Qualification
Required
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
Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering
Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation such as autoclaves, parts washers, clean steam generator, WFI pretreatment RO, WFI stills, filter integrity testers, wastewater treatment systems, and integrating various OEM automation software
Extensive understanding and background in programming, design, installation, and lifecycle management of standalone controls, PLC, and field device/instrumentation technologies
Experience with Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet 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
Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution
Hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations
Experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations
The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making
Strong leadership, technical writing, and communication/presentation skills
Benefits
Competitive and comprehensive Total Rewards Plans
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
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