Description
**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
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 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 Amgen’s plan to be a carbon-neutral company by 2027.
**Senior Manufacturing Systems Engineer** **:** **Automation**
**Live**
**What you will do**
Let’s do this. Let’s change the world. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. ** **
***The schedule for this position will be: 4 days x** **10 hour** **shift: Wednesday through Satur** **day.***
In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant. This includes complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.
Responsibilities:
+ Develop andmaintainthe process control system onEmersonDeltaVdistributed controlsystem(DCS).
+ Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
+ Collaborate with business partners to understandhowautomationcan improve workflow and productivity. Synthesize requirements from clients,customersor end-users to develop the best automation solutions.
+ Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in aGxPenvironment. Maintain Data Integrity Assessments with the current Amgen and Industry standards.
+ Build the business processes to support theprojectscope in alignment with project timelines. Develop detailedspecificationand engineering policies and procedures that affect multiple organizational units.
+ Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
+ On-going operations:
+ Own and drive tocompletionChange Controls, CAPAs, and Deviations.
+ Lead and support functional area projects focused on improving processequipment/utilities/facilitiesas well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
+ Leadandsupport technical root cause analysis, incident investigations, andtroubleshooting onprocess control issues related to plant operations.
+ Lead and support new product introductions (NPI) ornew technologyintroductions by performingautomationengineering assessments, implementingautomationsystem configurationchanges,and supporting engineering and process qualification runs as applicable.
+ Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations,Process andUtilityAutomatonsystems,Preventive andCorrectiveMaintenance,SystemAdministration,andAutomation Systemspare parts management.
+ Prepare/review Standard Operating Procedures (SOP) and cGMP documents.
+ Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications.
**Basic Qualifications:**
+ High School Diploma / GED and10years of Engineering experience OR
+ Associate’s Degreeand8years of Engineering experience OR
+ Bachelor’s Degree and4years of Engineering experience OR
+ Master’sDegree and2years of Engineering experience OR
+ DoctorateDegree
**Preferred Qualifications:**
+ Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or relatedfield.
+ Direct knowledge of Automation System design, experience inprocess control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automationsuch asmedia, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software.
+ Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls,automationand field instrumentation technologies.
+ Experience with EmersonDeltaVDCS system, Process Control Network design including network segregation,virtualinfrastructure design and implementation,and ability to perform advanced troubleshooting activities,systemintegration using OPC, Foundation Fieldbus, Profibus, andDeviceNettechnologies.Experience withDeltaVLive is preferred.
+ Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environmentwith requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95.
+ Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
+ Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
+ Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g. cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.
+ The ideal individual must be a 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.
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
+ Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans and bi-annual company-wide shutdowns
+ Flexible work models, including remote work arrangements, where possible.
**Apply now**
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
**#AmgenNorthCarolina**
