layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation at Amgen | LAYIQ

Let’s do this! Let’s change the world! In this vital role, you will serve as a subject matter expert in automation engineering, driving innovation, solving complex challenges, and influencing the design and implementation of automation systems for upstream and downstream bioprocessing. You will collaborate across engineering, manufacturing, and quality teams to ensure robust, compliant, and scalable automation solutions that support 24/7 operations.
The Principal Manufacturing Systems Engineer will join the Facilities & Engineering (F&E) group. This role will partner closely with the corporate engineering team during the design, build, commissioning, and qualification phases and later transitioning to supporting daily operations for drug substance production. This role will be instrumental in developing automation domain expertise and supporting operational readiness.
Job responsibilities include: Site design, construction, start-up, and operational readiness: Support design reviews while partnering closely with the corporate engineering team to represent site interests and requirements.
Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements, while working in partnership with global engineering during site installation. Ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery.
Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarily utilizing Emerson DeltaV Distributed Control System (DCS).
Lead commissioning and qualification efforts, including Automation Installation Verification/Automation Check Out (IV/ACO), ensuring compliance with GMP and project timelines.
Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls.
Provide mentoring to develop and accelerate site technical automation capabilities.
Site Operations: Act as responsible system owner for automation systems, providing day-to-day automation support including 24 x 7 onsite/on-call support, troubleshooting, and daily automation team meetings.
Provide technical leadership to troubleshoot, identify and resolve process and system issues as needed.
Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners).
Perform automation change assessments, implement automation system configuration changes, and support engineering and process qualification runs.
Lead continuous improvement initiatives including improvements to safety, reliability, efficiency, and sustainability, such as cycletimes, yields, and efficiency of unit operations in manufacturing.
Perform and maintain data integrity in accordance with the current Amgen and industry standards.
Serve as a technical mentor to junior engineers and cross-functional teams.
Influence automation strategy and standardization across the site and network.
Represent plant automation in Amgen global network forums related to automation and process control.
Represent automation during audits, and regulatory inspections.
Stay current with emerging technologies and industry trends to identify opportunities for innovation.
Provide strategic, tactical management, and leadership to ensure 24x7 day-to-day reliability of plant operations.
Up to 10% domestic/international travel

Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation

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