Senior Manufacturing Systems Engineer – DeltaV Batch

Amgen•Holly Springs, NC

1d•Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is pioneering the world of biotech in its fight against the world’s toughest diseases. With a focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – Amgen reaches millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines. Amgen's newest and most advanced drug substance manufacturing plant, the FleX batch facility, combines the latest in disposable technologies with traditional stainless steel equipment for maximum flexibility. The facility will feature best-in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. In this vital role as a member of the Facilities & Engineering (F&E) group, you will lead technical projects, drive innovation, and support manufacturing’s upstream, downstream, and solution preparation automation needs. You will solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations. You will partner closely with the capital project team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise to support operations upon start-up, focusing on manufacturing automation.

Requirements

High School Diploma / GED and 10 years of Engineering experience OR Associate’s Degree and 8 years of Engineering experience OR Bachelor’s Degree and 4 years of Engineering experience OR Master’s Degree and 2 years of Engineering experience OR Doctorate Degree
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.
Direct knowledge of integrating various OEM automation software and field instrumentation technologies.
Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation.
Experience with upstream/downstream /solution prep unit operations such as media, harvest, mixers, bioreactors, chromatography, viral filtration and ultrafiltration/ diafiltration among others.
Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation 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 in Capital Project Lifecycle Management including conceptual design, basis of design, detailed design, implementation, and validation.
Self-directed team player ready 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.

Nice To Haves

Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.

Responsibilities

Provide support to the capital project team with a strong focus on safety and on-time facility start- up.
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) for upstream, downstream, and/or solution prep operations.
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.
Develop and maintain detailed specifications, SOPs and operating standards that impact multiple organizational units.
Provide mentoring to develop and accelerate site technical automation capabilities.
Act as system owner for Upstream, Downstream , and/or Solution prep Automation processes.
Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Process and Utility Automaton systems, and Automation System spare parts management.
Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as capital projects to integrate new drug substance manufacturing technologies into the facility.
Lead and support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.
Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.
Prepare and review Standard Operating Procedures (SOP) and cGMP documents.