Senior Manager Manufacturing Systems Engineering

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

Location

United States , Holly Springs

Salary:

148715.15 - 201202.85 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of engineering experience OR Associate’s degree and 10 years of engineering experience OR Bachelor’s degree and 8 years of engineering experience OR Master’s degree and 6 years of engineering experience OR Doctorate degree and 2 years of engineering experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Degree in Electrical Engineering, Computer Science, Chemical Engineering or Biotech Engineering
Extensive experience with Emerson DeltaV, Process Control Network design including network segregation, Process Control Systems: Virtual Infrastructure design and implementation, System Integration using OPC, Foundation Fieldbus, and Profibus
Hands on experience with IO-Link technology for smart sensor/actuator integration in automated manufacturing environments
Familiarity with Process Analytical Technology (PAT) tools and strategies for real-time process monitoring and control in biopharmaceutical manufacturing
Direct knowledge of integrating various OEM automation software 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 working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Experience with Tech Transfer, Process Design, and Commissioning & Qualification

Job Responsibility

Oversee the Automation Engineering team, lead technical projects, and drive innovation and support manufacturing’s automation needs
Solve complex engineering problems and ensure the company's engineering efforts align with strategic objectives
Provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations
Build and lead a team of Automation engineering professionals and serve as the main point of contact for the Automation engineering function
Support design reviews while partnering closely with the corporate engineering team
Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements
Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarily utilizing Emerson DeltaV Distributed Control System (DCS)
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
Provide mentoring to develop and accelerate site technical automation capabilities

What we offer

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

Fulltime

Senior Manager, Manufacturing Engineering

The Manufacturing Engineering team at Lunar Energy is responsible for developing...

Location

United States , Mountain View

Salary:

182000.00 - 220000.00 USD / Year

Lunar Energy

Expiration Date

Until further notice

Requirements

You are passionate about accelerating the adoption of renewables and improving our energy infrastructure
Experience with power electronics manufacturing, including battery, inverter, and PCBA manufacturing processes
BS in Engineering (Mechanical, Electrical, Industrial)
MS in Engineering preferred
Experience with one or more of the following types of manufacturing equipment: laser welders, leak testers, automated conveyance, robotic pick and place, vision systems.
3+ years of experience managing manufacturing or process engineering teams.
8+ years in a manufacturing environment developing/improving processes, designing equipment, and/or overseeing equipment rollout and buyoff.
Ability to manage product development work with a focus on prototyping efforts
Proven track record of developing and launching production processes with a strong OEE
Familiarity with statistical process control and analysis of quality issues

Job Responsibility

Provide technical and managerial support to a diverse team of manufacturing engineers responsible for process and equipment development for manual and automated lines.
Set and execute Lunar’s strategy around manufacturing capital equipment technologies, complexity and scale.
Drive DFM/A feedback with our engineering teams to optimize our designs for cost and quality at our suppliers and for final assembly.
Review and approve fundamental manufacturing analyses from your team including PFMEAs, work instruction, line layout, capacity evaluation, and more.
Provide onsite support and supervision to the installation and ramp of new manufacturing lines at our various contract manufacturing (CM) partners.
Develop, maintain and track a multi-million dollar capital equipment budget for our manufacturing investments.
Collaborate with design engineering teams, equipment vendors, and manufacturing partners to design a manufacturing process that meets our product requirements and capacity objectives.
Manage all process development for early phase builds and define the roadmap in order to scale them for mass production.
Present to executive leadership on the status of line development, capacity and ramp throughout the life of the programs.
Collaborate with the Supplier Quality and Global Supply Management teams to resolve part quality issues using failure analysis, root cause and corrective actions.

What we offer

Medical, dental, and vision insurance for employees and dependents
Flexible Paid Time Off plus 10 paid holidays
Tax deferred 401(k) plan
Paid parental leave for all full time employees including 12 weeks paid parental leave for the birthing mother and 6 weeks paid parental leave for the non-birthing parent
Subsidized EV charging and pre-tax commuter benefits
Equity in a fast-growing company and participating in our employee stock program

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

Senior Manager, Factory Automation Engineering

This is a high-impact, critical leadership position focused on building, leading...

Location

United States , Indianapolis

Salary:

Not provided

Dandy

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Engineering, Physics, or Mathematics
Minimum of 7+ years of progressive experience in high-volume Manufacturing, Process, or Automation Engineering
Minimum of 3+ years managing an engineering team, with demonstrated success in hiring, talent development, and setting technical culture
Expert knowledge of Lean Manufacturing and Six Sigma and the ability to apply statistical methods (SPC, DOE)
Proven track record of overseeing the full lifecycle of automated equipment and successfully scaling manufacturing operations to high-volume production
Demonstrated ability to own and drive top-level production metrics (OEE, Yield) for a significant manufacturing area or facility
Exceptional leadership and communication skills for presenting strategy, negotiating resources, and engaging executive stakeholders
Ability to travel 50-75% of time in first 2-3 months to Provo, UT

Job Responsibility

Define the technical strategy and execution plan for automation development within the facility
Recruit, hire, and mentor the entire Facility Automation Engineering team
Establish a facility culture focused on ownership, data-driven decisions, and continuous improvement
Oversee all planning and execution for new equipment qualification (IQ/OQ/PQ)
Be accountable for achieving and sustaining world-class Overall Equipment Effectiveness (OEE) and performance targets
Mandate high standards for engineering quality - rigorous hypothesis testing, clear and effective documentation, use of tools such as statistical process control
Direct cross-functional efforts and champion DMAIC/DOE to drive systemic cost and performance gains
Architect and implement systems and protocols to guarantee continuous production uptime
Serve as the primary technical and operational leader for the site, providing executive level updates
Ensure the team strictly adheres to all Environmental, Health, Safety, and Security policies

What we offer

Healthcare
Dental
Mental health support
Parental planning resources
Retirement savings options
Generous paid time off

Fulltime

Senior Manager Manufacturing – Production Process Owners

In this vital role you will be a people leader and cross-functional integrator r...

Location

United States , Thousand Oaks

Salary:

154173.00 - 208587.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Manufacturing and Operations experience
Master’s degree and 6 years of Manufacturing and Operations experience
Bachelor’s degree and 8 years of Manufacturing and Operations experience
Associate’s degree and 10 years of Manufacturing and Operations experience
High school diploma / GED and 12 years of Manufacturing and Operations experience
Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Bachelor’s degree in Life Sciences, Physical Sciences, Engineering, or a related technical discipline
8+ years of manufacturing, operations, technical operations, or process support experience in biotechnology, biopharmaceutical, pharmaceutical, or other highly regulated manufacturing environments
6+ years of leadership experience, including direct people leadership and/or leadership of cross-functional teams, programs, or site-level initiatives
2+ years of experience managing, coaching, or developing direct reports, technical teams, process owners, or matrixed contributors

Job Responsibility

Lead, coach, mentor, and develop the manufacturing process owners within the manufacturing organization
Foster a culture of collaboration, continuous improvement, accountability, and high performance across the team
Provide guidance, performance feedback, and support for career development plans for direct reports
Set clear priorities, define role clarity, and establish coverage plans so the PPO team can flex across site needs
Ensure strong collaboration and coordination between Manufacturing and key partners
Provide governance and execution support to ensure smooth, compliant, and reliable manufacturing operations
Manage and improve manufacturing processes to increase productivity, reduce waste, and maintain product quality and compliance
Strengthen process discipline, documentation quality, and operational readiness across site processes
Serve as an escalation point for complex execution topics
Ensure manufacturing activities are performed in compliance with cGMP and all applicable regulatory requirements

What we offer

A 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
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

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Senior Manager Manufacturing Systems Engineering - Automation

Job Description

Job Responsibility

Requirements

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What we offer

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