Senior Manager Manufacturing Systems Engineering

Amgen•Holly Springs, NC

1d•Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a biotechnology pioneer since 1980, focused on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. This role is part of Amgen's newest and most advanced drug substance manufacturing plant, the FleX batch facility, which combines single-use and traditional stainless steel equipment with industry 4.0 capabilities and sustainability innovations. The facility aims to be carbon-neutral by 2027. The Senior Manager Manufacturing System Engineering will oversee the Automation Engineering team, lead technical projects, drive innovation, and support manufacturing automation needs. This role involves solving complex engineering problems, ensuring alignment with strategic objectives, and providing leadership for 24/7 manufacturing and facility operations. The position reports to the Facilities & Engineering (F&E) Director and will partner with the corporate engineering team during design, build, commissioning, and qualification phases. Key responsibilities include developing automation domain expertise, supporting operational readiness, and hiring/training staff for startup and operations.

Requirements

High school diploma / GED and 12 years of engineering experience OR Associate’s degree and 10 years of engineering experience OR Bachelor’s degree and 8 years of engineering experience OR Master’s degree and 6 years of engineering experience OR Doctorate degree and 2 years of engineering experience
A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or 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.
Direct knowledge of biopharmaceutical production facility with direct experience with 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.
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage

Responsibilities

Build and lead a team of Automation engineering professionals and serve as the main point of contact for the Automation engineering function.
Support design reviews while partnering closely with the corporate engineering team.
Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements.
Ensure 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).
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
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.
Lead a team of Automation engineer professionals and serve as the main point of contact for Automation engineering function.
Accountable for Automation System Administration, Automation System Operating Systems (OS) and HotFix assessments and rollout, preventative and corrective maintenance, Automation System spare parts management, and ownership of departmental Standard Operating Procedures (SOPs).
Manage day-to-day automation support including 24 x 7 onsite/on-call support, troubleshooting, and daily manufacturing and engineering meetings.
Establish clear expectations and priorities to staff.
Encourage a culture of continuous improvement, partnership, and knowledge sharing.
Provide development opportunities, feedback, and actively listen to staff.
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.
Represent automation in cross-functional design reviews and audits.
Look for new and innovative ways to do business differently, better and more cost effectively.
Lead continuous improvement initiatives including improvements to safety, reliability, efficiency, and sustainability.
Perform and maintain data integrity in accordance with the current Amgen and industry standards.
Provide technical support to troubleshoot, identify and resolve process and system issues as needed.
Provide strategic, tactical management, and leadership to ensure 24x7 day-to-day reliability of plant operations.
Participate in the budgeting process for Automation engineering, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.