Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation

Amgen•Holly Springs, NC

10d•$140,334 - $189,864•Onsite

About The Position

Amgen is seeking a Principal Manufacturing Systems Engineer specializing in Upstream/Downstream Process Automation for its new, advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility will integrate cutting-edge disposable technologies with traditional equipment, featuring industry 4.0 capabilities and sustainability innovations to support Amgen's goal of becoming a carbon-neutral company by 2027. The role is within the Facilities & Engineering (F&E) group and will be crucial during the design, build, commissioning, and qualification phases, eventually transitioning to support daily operations. This position is instrumental in developing automation expertise and ensuring operational readiness for drug substance production.

Requirements

Doctorate degree and 2 years of engineering experience OR Master’s degree and 4 years of engineering experience OR Bachelor’s degree and 6 years of engineering experience OR Associate’s degree and 10 years of engineering experience OR High school diploma / GED and 12 years of engineering experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Nice To Haves

Degree in Electrical Engineering, Computer Science, Chemical Engineering or Biotech Engineering.
Extensive experience with Emerson DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus.
Hands-on experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments.
Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time process monitoring and control in biopharmaceutical manufacturing.
Direct knowledge of integrating various OEM automation software and field instrumentation technologies.
In-depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
Deep understanding of biopharmaceutical manufacturing processes including Upstream (Seed train, production Bioreactors, Harvest), and Downstream Purification (e.g. Chromatography and viral Filtration skids, UFDF), and CIP/SIP Skids.
Ability and willingness 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.
Proven ability to influence cross-functional teams and drive technical decisions.
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

Responsibilities

Support design reviews, representing site interests and requirements in collaboration with the corporate engineering team.
Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements, ensuring operational capability and compliance.
Collaborate with the site process engineering team to develop process control automation solutions, primarily using Emerson DeltaV Distributed Control System (DCS).
Lead commissioning and qualification efforts, including Automation Installation Verification/Automation Check Out (IV/ACO), ensuring GMP compliance and project timelines.
Partner with various organizational units to support operational readiness, document reviews, deviation investigations, and change controls.
Provide mentoring to develop and accelerate site technical automation capabilities.
Act as responsible system owner for automation systems, providing day-to-day automation support, including 24x7 onsite/on-call support, troubleshooting, and daily automation team meetings.
Provide technical leadership to troubleshoot, identify, and resolve process and system issues.
Collaborate effectively 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 to enhance safety, reliability, efficiency, and sustainability, such as improving cycletimes, yields, and efficiency of unit operations.
Perform and maintain data integrity in accordance with 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.