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Provide automation technical leadership to a group of Automation Engineers who are responsible to build and maintain various automation systems and platforms that support the GMP Drug Substance Plant Operations. Work hand in hand with the capital project team to deliver robust automation systems to operate the new plant. This includes sophisticated and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.
Job Responsibility:
Develop and maintain process control automation solutions using DeltaV Distributed Control System (DCS), Human Machine Interfaces (HMI), and Building Management Systems (BMS)
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 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
Build the business processes to support the project scope in alignment with project timelines
Provide rotational automation on-call support for manufacturing operations
Maintain detailed specification and engineering policies and procedures that affect multiple organizational units
Assist in the cultivation of a robust talent pipeline with diverse capabilities required to thrive in the present and future based on perception of team needs. Partner with the Sr. Manager and HR to recruit, coach, develop, empower, and retain staff. Ensure an ongoing organizational structure capable of adapting to evolving business needs
Establish technical training, leadership training, and cross-training plans to continually develop staff and build breadth and depth in the organization
Act as an expert resource for helping fellow automation engineering staff to build out robust long-term development plans aligned with their aspirations
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 process control issues related to plant operations
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
Provide day-to-day Operational Support including: Automation System Administration, Automation System Operating Systems (OS) HotFix assessments and rollout, 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
Requirements:
High school diploma / GED and 12 years of Manufacturing Automation Engineering experience
Associate degree and 10 years of Manufacturing Automation Engineering experience
Bachelor’s degree and 6 years of Manufacturing Automation Engineering experience
Master’s degree and 4 years of Manufacturing Automation Engineering experience
Doctorate degree and 2 years of Manufacturing Automation Engineering experience
Nice to have:
Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering
Direct knowledge of Automation design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, chromatography, vial filtration, ultrafiltration/diafiltration, and integrating various OEM automation software
Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies
Experience with Emerson Delta-V DCS system, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation and ability to perform sophisticated troubleshooting activities with Amgen IS, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
A degree of high-level experience with standalone PLC systems and/or Siemens Desigo BAS is not a requirement, but would be beneficial to the role
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
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 standout colleague 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
What we offer:
Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards