Bioprocess Automation Architect for Upstream/Downstream

BioSpace

Holly Springs (NC)

On-site

USD 140,000 - 190,000

Full time

33 hours ago

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Job summary

Amgen in North Carolina's Holly Springs facility is seeking a Principal Manufacturing Systems Engineer focused on Upstream/Downstream Process Automation. You will drive automation strategy and deliver compliant, scalable solutions for 24/7 bioprocess operations.

In this role you will lead commissioning, IV/ACO, and change control activities, partnering with engineering, manufacturing and quality teams to ensure robust automation and continuous improvement across the site.

Qualifications

Doctorate degree and 2 years of engineering experience
OR
Masters degree and 4 years of engineering experience
OR
Bachelors degree and 6 years of engineering experience
OR
Associates degree and 10 years of engineering experience
Or
High school diploma / GED and 12 years of engineering experience
And
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Responsibilities

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