Senior Manufacturing Systems Engineer – DeltaV

SeniorManufacturingSystemsEngineer DeltaV

What youwill 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 strategicobjectives. 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 andqualifynew equipment and systems needed for drug substance production. This role will develop domainexpertiseto 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 primarilyutilizingEmersonDeltaVDistributed Control System (DCS) forupstream downstream and/or solution prepoperations.

• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).

• Partner with various organizational units to support tasksincluding operational readiness document reviews deviationinvestigationand change controls.

• Develop andmaintaindetailed specificationsSOPsand operating standards thatimpactmultiple organizational units.

• Provide mentoring to develop and accelerate site technical automation capabilities.

• Site Operations:

• Act as system owner forUpstreamDownstream and/or Solution prepAutomation 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 andAutomation Systemspare parts management

• Lead and support functional area projects focused on improving processequipment/utilities/facilitiesas well as capital projects to integrate new drug substance manufacturing technologies into the facility.

• Lead and support 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.

• Prepare and review Standard Operating Procedures (SOP) and cGMP documents.

• On-site roleand up to 10% domestic/international travel

What we expectofyou

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 and 10 years of Engineering experience OR

• Associates Degree and 8 years of Engineering experience OR

• Bachelors Degree and 4 years of Engineering experience OR

• Masters Degree and 2 years of Engineering experience OR

• Doctorate Degree

Preferred Qualifications:

• Degree in Electrical Engineering or Computer Science ChemicalEngineeringorBiotech 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.

• Direct knowledge of integrating various OEM automation software and field instrumentation technologies.

• Direct knowledge of Automation System design experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation.

• Experiencewith upstream/downstream/solution prepunit operations such as media harvest mixers bioreactors chromatography viral filtration and ultrafiltration/diafiltrationamong others.

• Extensive understanding and background in programming design installation and lifecycle management of manufacturing process controlsautomationand field instrumentation technologies.

• In-depth knowledge of industry standards such as 21 CFR Part 11 ASTM 2500 S88 S95 GAMP GDP and GMP.

• Experience in Capital Project Lifecycle Management including conceptual design basis of design detailed design implementation and validation.

• 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.

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.