Senior Manufacturing Systems Engineer Automation DeltaV (Swing Shift Monday Friday)

ANC1 F&E Engineering

HOW MIGHT YOU DEFY IMAGINATION

If you feel likeyourepart of something biggeritsbecause you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the AmgenFleXbatch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch 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:Automation- DeltaV

Live

What you will do

Letsdo this.Letschange the world.AsaSeniorManufacturing SystemsEngineeryou will provideautomationtechnical leadership to a group ofautomationengineerswhoare responsible forbuilding andmaintainingvarious automation systems and platforms that support the GMP DrugSubstancePlant Operations.

*The schedulefor this position willbe:SwingShift3pm - 11pm: MondaythroughFriday.*

In this vital roleas a member of the Facilities & Engineering (F&E) Automationteamyou will work hand in hand with the capital project team to deliver robustprocessautomation systems tooperatethe 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 lifecyclemanagementand 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 clientscustomersor 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 configurationchangesand 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. OperationsProcess andUtilityAutomatonsystemsPreventive andCorrectiveMaintenanceSystemAdministrationandAutomation 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 weseekis an engineer with these qualifications.

Basic Qualifications:

• High School Diploma / GED and10years of Engineering experience OR

• Associates Degreeand8years of Engineering experience OR

• Bachelors Degree and4years of Engineering experience OR

• MastersDegree 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 controlsautomationand field instrumentation technologies.

• Experience with EmersonDeltaVDCS system Process Control Network design including network segregationvirtualinfrastructure design and implementationand ability to perform advanced troubleshooting activitiessystemintegration 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 Plancomprisinghealth 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

for a career that defies imagination

In our quest to serve patientsabove all else Amgen is the first to imagine and the last to doubt. Join us.

#AmgenNorthCarolina