Senior Manager Manufacturing Systems Engineering Job at Amgen (Holly Springs)

Senior Manager Manufacturing Systems Engineering - Automation

Senior Manager Manufacturing Systems Engineering - Automation at Amgen's newest ...

Location

United States , Holly Springs

Salary:

163288.40 - 220919.60 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Engineering and/or Project Management experience OR Associate's degree and 10 years of Engineering and/or Project Management experience OR Bachelor's degree and 8 years of Engineering and/or Project Management experience OR Master's degree and 6 years of Engineering and/or Project Management experience OR Doctorate degree and 2 years of Engineering and/or Project Management experience
Additionally: in addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Job Responsibility

Providing technical and administrative leadership to a group of Automation Engineers accountable for administrating and maintaining automation systems for Drug Substance manufacturing at Amgen North Carolina (ANC)
Meeting key performance metrics, leading and technically developing reports, and ensuring all targets and turning points are completed on time
Ensuring the automation team applies the Corporate Automation Business Processes and drivers to deliver the automation services to the organization
Lead a team of Automation Engineers and serve as the main point of contact for automation function for ANC1 manufacturing
Define, drive, and deliver the automation and process control strategy within Drug substance manufacturing
Serve as an experienced advisor to senior level management and ensure the automation development strategy aligns with Amgen Process Development strategy
Strategic and tactical management and leadership in providing 24x7 day-to-day operational support, mentoring, staff development, team productivity, and efficient use of available resources
Develop support structures with internal/multi-functional teams for capital projects, plant support, and Amgen network-level initiatives' execution
Provide input into department objectives and establishing strategic direction within the Drug Substance Network for the F&E automation team
Maintain and improve capabilities and automation systems reliability in partnership with F&E and plant leadership, and other technical staff in the network, focusing on Maintenance Excellence systems failures and recurrence avoidance

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
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 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 Engineering Manager

Location

Mexico , Saltillo

Salary:

Not provided

BorgWarner

Expiration Date

Until further notice

Requirements

Engineering (master’s degree in manufacturing, Operations or MBA preferred)
Advanced English required (negotiation and executive presentations)
Senior-level manufacturing engineering leadership experience in the automotive industry (Tier-1 preferred)
Proven track record in operations, program launches, and capital projects management
Strong project management, problem-solving, and team development capabilities
+10 years in automotive manufacturing or similar industry
Experience leading Engineering and/or Operations at the management level
Proven implementation of Lean Manufacturing
High-impact CAPEX project management
Experience in machining, CNC, grinding and assembly

Job Responsibility

Responsible for defining, leading and executing the Engineering and Operational Excellence (OPEX) strategy of the campus, ensuring technical competitiveness, productivity, profitability and operational sustainability of the business
Directs the standardization and optimization of manufacturing processes (Machining and Assembly), guaranteeing compliance with Safety, Quality, Deliveries and Costs, as well as the effective deployment of the lean culture and continuous improvement, with a direct impact on financial results and return on investment
This position will cover responsibilities across three different facilities within the Saltillo campus, overseeing a team of approximately 20 engineers and 2 area superintendents, with direct report to the Plant General Manager
Responsibility for all campus engineering processes
Leadership of the Lean/OPEX department
Responsible for compliance with annual committed savings
Capital project governance (CapEx)
Direct impact on OEE, PPM, Scrap, Productivity and Costs
Responsible for the technical pipeline and succession in Engineering
Oversee and improve key operational KPIs across all running production lines: OEE (Overall Equipment Effectiveness), FTQ (First Time Quality), Cost of Tooling vs. Sales

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

Senior Manager Manufacturing Programs

Reporting to the Director of Manufacturing Support, this position is responsible...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Process Development, Engineering or Manufacturing experience OR Master’s degree and 6 years of Process Development, Engineering or Manufacturing experience OR Bachelor’s degree and/or 8 years of Process Development, Engineering or Manufacturing experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
In depth business understanding of manufacturing or operations in biotechnology, biopharmaceuticals or pharmaceuticals industry
8+ years of experience in process development, engineering, manufacturing technical support or manufacturing operations
6+ years of leadership experience with two or more years as a cross-functional team leader including experience in performance management, technical problem solving, and managing projects (or equivalent/lateral experience)
4+ years of experience operating in a cGMP environment
Excellent communication skills, drive, sense of urgency, energy level and problem-solving abilities
Ability to recommend, judge, and make good decisions in complex situations
Ability to responsibly and professionally address difficult business and personnel issues
manage conflict effectively with demonstrated negotiating, partnering and influencing skills

Job Responsibility

Responsible for providing process ownership for multiple biologic/synthetic products as well as introduction of new products into the manufacturing facility
Responsible for overseeing all activities of new product/technology introductions and multi-product campaigns in a compliant, agile and cost-effective manner
Responsible for overseeing all activities associated with cleaning validation and managing the validated state of process equipment
Responsible for contamination control and inspection readiness for manufacturing
Provides direct leadership to production interruption investigation and serve as escalation point for resolving process (including single use)/equipment related issues
Manages deviations, change controls, corrective actions and preventative actions associated with products and process equipment
Manages the implementation and development of the electronic batch records
Drives a culture of continuous improvement
Drives/supports site wide technical and non-technical continual improvement initiatives, programs and projects to increase production and disposition agility
Presents key investigations and quality management system records in site regulatory inspections

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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

Industrial Engineering Senior Manager

In this role, you will have the opportunity to directly lead a Industrial Engine...

Location

United States , Everett

Salary:

159800.00 - 216200.00 USD / Year

Boeing

Expiration Date

Until further notice

Requirements

Bachelor's degree or higher
3+ years of experience driving and implementing continuous improvement in a production facing role
1+ years of experience in Industrial Engineering or equivalent area
1+ years of experience in a management position with direct reports

Job Responsibility

Manages employees and first-level managers applying industrial engineering techniques and concepts to optimize production system design and operational efficiency
Develops and executes integrated departmental plans, policies and procedures and provides input on departmental business and technical strategies, goals, objectives
Acquires resources for department activities, provides technical management of suppliers and leads process improvements
Develops and maintains relationships and partnerships with customers, stakeholders, peers, partners and direct reports
Provides oversight and approval of technical approaches, products and processes
Manages, develops and motivates employees and first-level managers

What we offer

health insurance
flexible spending accounts
health savings accounts
retirement savings plans
life and disability insurance programs
paid and unpaid time away from work
generous company match to 401(k)
industry-leading tuition assistance program
fertility, adoption, and surrogacy benefits
up to $10,000 gift match

Fulltime

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Senior Manager Manufacturing Systems Engineering

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