Manufacturing Systems Engineer: Automation Job at Amgen (Holly Springs)

Manufacturing Systems Engineer: Automation

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Holly Springs

Salary:

105362.60 - 142549.40 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and 8 years of Engineering experience OR Associate’s Degree and 6 years of Engineering experience OR Bachelor’s Degree and 2 years of Engineering experience OR Master’s Degree
Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, 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
Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies
Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies
Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies
Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95
Self-directed team player able to work cross-functionally
Strong technical writing and communication skills

Job Responsibility

Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS)
Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
Provide clear documentation for delivered solutions and processes
Support QA partners in performing computerized systems validation in a GxP environment
Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
Support process automation systems to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment
Own and drive to completion Change Controls, CAPAs, and Deviations

What we offer

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

Fulltime

Manufacturing Systems Engineer: Automation

As a Manufacturing Systems Engineer, you will work with a group of automation en...

Location

United States , Holly Springs

Salary:

118497.00 - 134250.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and 8 years of Engineering experience
Associate’s Degree and 6 years of Engineering experience
Bachelor’s Degree and 2 years of Engineering experience
Master’s Degree
Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation
Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies
Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies
Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies
Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95

Job Responsibility

Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS)
Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
Provide clear documentation for delivered solutions and processes
Support QA partners in performing computerized systems validation in a GxP environment
Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
Support process automation systems to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment
Own and drive to completion Change Controls, CAPAs, and Deviations

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Manufacturing Systems Engineer: Automation

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger...

Location

United States , Holly Springs

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Basic Qualifications: High School Diploma / GED and 10 years of Engineering experience OR Associate's Degree and 8 years of Engineering experience OR Bachelor's Degree and 4 years of Engineering experience OR Master's Degree and 2 years of Engineering experience OR Doctorate Degree
Preferred Qualifications: Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, 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, automation and field instrumentation technologies
Experience with Emerson DeltaV DCS system, Process Control Network design including network segregation, virtual infrastructure design and implementation, and ability to perform advanced troubleshooting activities, system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies. Experience with DeltaV Live is preferred
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with 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

Job Responsibility

Develop and maintain the process control system on Emerson DeltaV distributed control system (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 understand how automation can improve workflow and productivity
Synthesize requirements from clients, customers or 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 a GxP environment
Maintain Data Integrity Assessments with the current Amgen and Industry standards
Build the business processes to support the project scope in alignment with project timelines
Develop detailed specification and 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

What we offer

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

Fulltime

Senior Manufacturing Systems Engineer: Automation (Wednesday - Saturday Shift)

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

136906.95 - 185227.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

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

Job Responsibility

Develop and maintain the process control system on Emerson DeltaV distributed control system (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 understand how automation can improve workflow and productivity
Synthesize requirements from clients, customers or 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 a GxP environment
Maintain Data Integrity Assessments with the current Amgen and Industry standards
Build the business processes to support the project scope in alignment with project timelines
Develop detailed specification and 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

What we offer

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

Fulltime

Senior Manufacturing Systems Engineer: Automation

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

147421.00 - 177467.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and 10 years of Engineering experience
Associate’s Degree and 8 years of Engineering experience
Bachelor’s Degree and 4 years of Engineering experience
Master’s Degree and 2 years of Engineering experience
Doctorate Degree
Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
Direct knowledge of Automation System design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation
Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies
Experience with Emerson DeltaV DCS system, Process Control Network design including network segregation, virtual infrastructure design and implementation, and ability to perform sophisticated troubleshooting activities, system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95

Job Responsibility

Provide automation technical leadership to a group of automation engineers
Work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant
Develop and maintain the process control system on Emerson DeltaV distributed control system (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 understand how automation can improve workflow and productivity
Synthesize requirements from clients, customers or 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 a GxP environment
Maintain Data Integrity Assessments with the current Amgen and Industry standards
Build the business processes to support the project scope in alignment with project timelines

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Manufacturing Systems Engineer: Automation - PLC

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

147421.00 - 177467.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and 10 years of Engineering experience
Associate’s Degree and 8 years of Engineering experience
Bachelor’s Degree and 4 years of Engineering experience
Master’s Degree and 2 years of Engineering experience
Doctorate Degree
Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering
Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation
Extensive understanding and background in programming, design, installation, and lifecycle management of standalone controls, PLC, and field device/instrumentation technologies
Experience with Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95

Job Responsibility

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
Work hand in hand with the capital project team to deliver robust automation systems to operate the new plant utility and standalone systems
Develop and maintain automation solutions utilizing various PLC's such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system
Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLC’s and interface hardware
Lead and support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including power distribution, grounding requirements, I/O assignments, etc
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
Lead in continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems
Collaborate with business partners to understand how standalone systems can improve workflow and productivity. Synthesize requirements from clients, customers, or 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 a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Manufacturing Systems Engineer: Automation - PLC

As a Manufacturing Systems Engineer, you will work with a group of automation en...

Location

United States , Holly Springs

Salary:

118497.00 - 134250.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and 8 years of Engineering experience
Associate’s Degree and 6 years of Engineering experience
Bachelor’s Degree and 2 years of Engineering experience
Master’s Degree
Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering
Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation
Extensive understanding and background in programming, design, installation, and lifecycle management of standalone controls, PLC, and field device/instrumentation technologies
Experience with Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with 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

Job Responsibility

Develop and maintain automation solutions using various PLC's such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system
Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLC’s and interface hardware
Support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including power distribution, grounding requirements, I/O assignments, etc.
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
Assist in continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems
Collaborate with business partners to understand how standalone systems can improve workflow and productivity. Synthesize requirements from clients, customers, or 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 a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards
Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units
Support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

New

Senior Manufacturing Systems Engineer - PLC Systems

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Holly Springs

Salary:

136906.95 - 185227.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and 10 years of Engineering experience OR Associate’s Degree and 8 years of Engineering experience OR Bachelor’s Degree and 4 years of Engineering experience OR Master’s Degree and 2 years of Engineering experience OR Doctorate Degree
Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering
Extensive experience with process and utility skid equipment, and direct knowledge of integrating various OEM automation software and field instrumentation technologies such as Rockwell platforms
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
Experience in programming, design, installation and lifecycle management of PLC and field device/instrumentation technologies
Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and 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

Job Responsibility

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 for PLC based systems
Work with platform leads to ensure standalone PLC based systems are designed with the proper network connectivity and system-to-system communication to enable centralized monitoring and alarming
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, deviation investigation and change controls
Develop and maintain detailed specifications, SOPs and operating standards that impact multiple organizational units
Provide mentoring to develop and accelerate site technical automation capabilities
Act as system owner for standalone PLC based systems
Manage Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, preventive and corrective maintenance, system administration, and Automation Systems spare parts management
Lead and support functional area projects focused on improving equipment/utilities/facilities as well as capital projects to integrate new drug substance manufacturing technologies into the facility

What we offer

competitive and comprehensive Total Rewards Plans

Fulltime

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