Amgen · 12 hours ago
Senior Manufacturing Systems Engineer: BAS/QBAS
US - North Carolina - Holly Springs
Full-time
Onsite
Mid, Senior Level
$147K/yr - $177K/yr
4+ years expAmgen is a leading biotechnology company dedicated to serving patients with serious illnesses. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership and collaborate with various teams to develop and maintain automation systems that support drug substance plant operations.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Maintain the Building Automation System (BAS)on Siemens Desigo CC
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
Collaborate with business partners to understand how utility and building equipment systems automation 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
Maintain detailed specification and engineering policies and procedures that affect multiple organizational units
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO)
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/support technical root cause analysis, incident investigations, and troubleshooting on utilities and building automation controls
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
Handle Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Utility systems, Utility and BAS Administration, 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 be more cost efficient
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 BAS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software
Extensive understanding and background in programming, design, installation and lifecycle management of building automation controls, PLC and field device/instrumentation technologies
Experience with Siemens Building Automation system, Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities with Amgen DTI, 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 implementation
Experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times, and reduced plant utilities usage etc.)
The ideal individual must be a self-directed excellent teammate 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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