Senior Manufacturing Systems Engineer Holly Springs, NC
Holly Springs, MS - USA
Job Summary
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.
Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.
Senior Manufacturing Systems Engineer DeltaV
What you will do
In this vital role as a member of the Facilities & Engineering (F&E) group you will lead technical projects and drive innovation and support manufacturings upstream downstream and solution preparation automation needs. You will solve complex engineering problems and ensure the companys 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.
Job responsibilities include:
Site design construction start-up and operational readiness:
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.
Site Operations:
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.
On-site role and up to 10% domestic/international travel
Required Experience:
Senior IC
About Company
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