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

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Remote work options

Job summary

Amgen in North Carolina seeks a Senior Manufacturing Systems Engineer for Automation-DeltaV to lead and elevate the automation stack of the new drug substance plant. You will coordinate with the capital project team to deliver robust process automation, develop and maintain DeltaV control systems, and drive lifecycle management aligned with GMP requirements.

The role requires strong engineering leadership, collaboration with SMEs, and experience across automation platforms, project management,

Qualifications

• High School Diploma / GED and 10 years of Engineering experience.
• Associates Degree and 8 years of Engineering experience.
• Bachelor's Degree and 4 years of Engineering experience.
• Masters Degree and 2 years of Engineering experience.
• Doctorate Degree.

Responsibilities

• Develop and maintain the DeltaV DCS for the plant.
• Collaborate with SMEs to translate process requirements into automation solutions.
• Lead change controls, CAPAs, and deviations.
• Support commissioning, validation and IV/ACO activities.
• Provide documentation and QA support in a cGMP environment.
• Provide 24x7 on-site/on-call operational support.

Skills

DeltaV

Automation

GMP

Process Control

Capital Projects

Team Leadership

Education

Bachelor's Degree

Master's Degree

Doctorate Degree

Tools

Emerson DeltaV

OPC

Foundation Fieldbus

Profibus

Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyourepart of something bigger,itsbecause 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.

ANC1 F&E Engineering

Be part of Amgen's 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 Amgen's 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 SystemsEngineer,you will provideautomationtechnical leadership to a group ofautomationengineerswhoare responsible forbuilding andmaintainingvarious automation systems and platforms that support the GMP DrugSubstancePlant Operations.

• The schedule for this position will be: Swing Shift 3pm - 11pm: Monday through Friday.

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 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 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 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 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 Plancomprisinghealth And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities ToSave 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