Senior Manager Manufacturing System Engineering - Bulk Drug Substance - Upstream
Senior Manager Manufacturing System Engineering - Bulk Drug Substance - Upstream
US - North Carolina - Holly Springs Apply NowJoin Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use 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 Amgen's plan to be a carbon-neutral company by 2027.
Senior Manager Manufacturing System Engineering- Bulk Drug Substance - Upstream
What you will do
Let’sdo this!Let’schange the world! In this vital role, you will oversee theAutomationEngineering team, lead technical projects, and drive innovation andsupportmanufacturing’sautomation needs. You will solve complex engineering problemsand ensure the company's engineering efforts align with strategicobjectives. You will also provide leadership and guidance to theAutomation Engineering team supporting 24/7 manufacturing and facility operations.
TheSeniorManagerManufacturing System Engineeringwill join the Facilities & Engineering (F&E) groupreporting to theFacilities & Engineering (F&E)Director. This role will partnerclosely with the corporate engineering teamduring thedesign, build, commissioning, and qualification phases.This role will be instrumental in developing automation domainexpertiseand supporting operational readinessandwill develop domainexpertiseto support operations upon start-up, focusing onmanufacturing automationas well as hiring and training the staff required to support startup and operations.
Job responsibilities include:
Sitedesign,construction, start-up, and operational readiness:
Build and lead a team ofAutomation engineeringprofessionals and serve as the main point of contact forthe Automation engineering function.
Support design reviews whilepartnering closely with the corporate engineering team.
Execute andsupport thecommissioning and qualification ofprocess equipmentautomationin 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.
Collaboratewiththe siteprocessengineering teamto understand key process requirements anddevelop process control automation solutionsprimarilyutilizingEmersonDeltaVDistributed 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, deviationinvestigationand change controls.
Provide mentoring todevelopand acceleratesitetechnicalautomationcapabilities.
SiteOperations:
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) andHotFixassessments and rollout, preventative and correctivemaintenance, AutomationSystem spare parts management, and ownership of departmental Standard Operating Procedures (SOPs).
Manageday-to-dayautomationsupport including 24 x 7onsite/on-callsupport, troubleshooting,anddailymanufacturing and engineeringmeetings.
Establish clear expectations and prioritiestostaff. Encourage a culture of continuous improvement, partnership, and knowledge sharing.Providedevelopment opportunities, feedback, and actively listen to staff.
Effectively collaborate with key customers and support groups (e.g.Manufacturing, Quality, Process Development, Maintenance, network partners)
Performautomationchangeassessments, implement automation system configuration changes,and supportengineering 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 andmaintaindataintegrityin accordancewiththe current Amgen andindustry standards.
Provide technical support to troubleshoot,identifyand resolve process and system issues as needed.
Provide strategic,tactical management,and leadershipto ensure24x7 day-to-dayreliability of plant operations.
Participate in the budgeting process forAutomation engineering, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.
Up to10% domestic/international travel
What we expect of you
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
And
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
Degree in Electrical Engineering,Computer Science, Chemical Engineering or Biotech Engineering.
Extensive experience with EmersonDeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus.
Handson 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 processmonitoringand control in biopharmaceutical manufacturing.
Direct knowledge of integrating various OEM automation software and field instrumentation technologies.
In-depth knowledge ofindustry standardssuch 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 tomentor and develop engineeringstaff andembrace a team-based culture that relies on collaboration for effective decision-making.
Strong leadership, technical writing, and communication/presentation skills.
Work schedule flexibility asrequiredto support 24/7 operations, requiring occasional after-hours engineering coverage