Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation

Amgen•Holly Springs, NC

8d•Onsite

About The Position

Amgen is seeking a Principal Manufacturing Systems Engineer to join their Facilities & Engineering (F&E) group at their newest and most advanced drug substance manufacturing plant. This role will be instrumental in developing automation domain expertise and supporting operational readiness for the FleX Batch facility, which combines cutting-edge disposable technologies with traditional equipment and integrates sustainability innovations. The engineer 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. This role involves collaboration across engineering, manufacturing, and quality teams to ensure robust, compliant, and scalable automation solutions that support 24/7 operations. The position will partner closely with the corporate engineering team during design, build, commissioning, and qualification phases, and later transition to supporting daily operations 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
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 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.
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.