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Sr Engineer - F&E EOS

Amgen

Thousand Oaks, CA; Juncos, PRHybridPosted 19 days ago$115,494.60 - $156,257.40
Full TimeSenior LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

In this vital role you will lead serve as the business process owner for maintenance process and CMMS capabilities, partnering with technical platform owners and related business process owners to the Engineering global organization at Amgen. You will also serve as primary system owner for the F&E AM and CI programs, being the liaison with the global and local Engineering and Asset Management, Sustainability and Reliability processes.

Job description

  • Drive development of Maintenance process strategy, operating model, standards, and long-term product roadmap in alignment with Engineering priorities
  • Serve as accountable business process owner for Maintenance, facilitating governance, resolving network process information request, design decisions or policy modifications.
  • Lead end-to-end design and standardization of maintenance work processes, including work requests, work order creation, prioritization, planning, scheduling, execution, completion, work history and feedback loop into supporting lifecycle processes and continuous improvement
  • Own the business product prioritization for maintenance capabilities in the CMMS platform; define business requirements, user requirements, process impacts, acceptance criteria and process outcome with global process leads and site stakeholders.
  • Partner with platform owners, vendors, and delivery teams to guide design, configuration decisions, integrations, testing, defect resolution, release readiness and controlled deployment; represent business needs without displacing technical platform accountability.
  • Align and sustain Maintenance processes with related global capabilities including Asset Management, Reliability/APM, Calibration and Metrology, MRO and Central Inventory, Procurement, Finance, Quality, Validation, EHS, Manufacturing and capital project delivery.
  • Provide business direction and approval for maintenance process and data activities across SAP EAM program related activities including migration, reconciliation, testing, cutover, readiness, hypercare, legacy-system transition, and operational handover, consistent with governance and delegated authority.
  • Partner with Quality, Validations and process owners to maintain compliant and inspection-ready process
  • Define and review global maintenance performance measures and operating reviews to drive continuous improvement actions based on performance data, audit/inspection observations, user experience, lessons learned, and business risk
  • Build and sustain a global Maintenance community of stakeholder network, engaging site leadership and users during design, decision-making, knowledge sharing and sustained process ownership
  • Partner with Reliability network on maintenance strategy, maintenance optimization and asset performance maintaining responsibility boundaries
  • Support asset lifecycle management with relevant business owners
  • Lead or participate in cross-functional initiatives affecting global Maintenance, operating processes, or network transformation
  • Support non-standard work hours, including weekend or extended hours as needed for global deployments

Basic Qualifications

  • Doctorate degree OR Master’s degree and 2 years of Engineering industry experience OR Bachelor’s degree and 4 years of Engineering industry experience OR Associate’s degree and 8 years of Engineering industry experience OR High school diploma / GED and 10 years Engineering industry experience

Preferred Qualifications

  • Engineering academic degree, advanced education or experience in maintenance, asset management, engineering operations or related discipline
  • Demonstrated experience leading global or multi-site maintenance processes, business transformation, enterprise product ownership or process governance
  • Proficient knowledge of end-to-end maintenance management, including work management, planning and scheduling, preventive maintenance, corrective maintenance, maintenance execution, and maintenance performance improvement
  • Experience as business process owner, global product owner, or functional lead for CMMS platform; SAP EAM experience is an advantage
  • Experience developing process strategies, global standards, roadmaps, prioritized backlogs, business requirements, release plans and measurable outcomes
  • Experience leading or supporting enterprise technology implementation activities, including process design, data migration, data governance, testing, deployment, change control, training, cutover, hypercare, and transition to steady state
  • Competent of GMP-regulated quality system and the application of validation, change control, documentation, records and training requirements to maintenance business process and system modifications
  • Ability to interpret and apply applicable GxP requirement and collaborate effectively with Quality, Validation and business process owners
  • Experience aligning maintenance with related functions such as Reliability, Asset Management, Calibration, Supply Chain/MRO, Finance, Quality, EHS, Manufacturing and Capital Projects
  • Ability to leverage operational and system data to monitor process performance, identify business risk and continuous improvement opportunities to support prioritization and investment decisions
  • Excellent written, verbal, facilitation and presentation skills, including communication with executive leaders, global workstreams and site practitioners
  • Proven ability to lead through influence, negotiate priorities, manage change, and work effectively across diverse teams and management styles
  • Strong project management skills with ability to manage multiple workstreams, dependencies, decision and timelines
  • Experience supporting regulatory inspection or audit readiness while translating findings into sustainable business-process improvement
  • Strong Reliability Engineering experience
  • Solid understanding of GMP regulated quality systems and business processes
  • Proven skills and knowledge in problem solving techniques, continuous improvement initiatives, asset management, reliability, utilities and facilities operations
  • Ability to interpret and apply GLPs and GMPs
  • Excellent communication (verbal and written) and presentation skills
  • Dealing with and handling change with a good planning skill
  • Project management skills with the ability to handle multiple projects at one time
  • Good negotiating expertise; skilled in facilitation and collaboration, interacting successfully with variety of communication and working styles
  • Experience using creativity to define solutions, focus on innovation and process improvements with the ability to delegate and lead the work of others
  • Regulatory knowledge, experience in regulatory agencies' interactions; Knowledge of Engineering financial process, budget management and cost analysis

Requirements

  • Doctorate degree OR Master’s degree and 2 years of Engineering industry experience OR Bachelor’s degree and 4 years of Engineering industry experience OR Associate’s degree and 8 years of Engineering industry experience OR High school diploma / GED and 10 years Engineering industry experience
  • Engineering academic degree, advanced education or experience in maintenance, asset management, engineering operations or related discipline
  • Demonstrated experience leading global or multi-site maintenance processes, business transformation, enterprise product ownership or process governance
  • Proficient knowledge of end-to-end maintenance management, including work management, planning and scheduling, preventive maintenance, corrective maintenance, maintenance execution, and maintenance performance improvement
  • Experience as business process owner, global product owner, or functional lead for CMMS platform; SAP EAM experience is an advantage
  • Experience developing process strategies, global standards, roadmaps, prioritized backlogs, business requirements, release plans and measurable outcomes
  • Experience leading or supporting enterprise technology implementation activities, including process design, data migration, data governance, testing, deployment, change control, training, cutover, hypercare, and transition to steady state
  • Competent of GMP-regulated quality system and the application of validation, change control, documentation, records and training requirements to maintenance business process and system modifications
  • Ability to interpret and apply applicable GxP requirement and collaborate effectively with Quality, Validation and business process owners
  • Experience aligning maintenance with related functions such as Reliability, Asset Management, Calibration, Supply Chain/MRO, Finance, Quality, EHS, Manufacturing and Capital Projects
  • Ability to leverage operational and system data to monitor process performance, identify business risk and continuous improvement opportunities to support prioritization and investment decisions
  • Excellent written, verbal, facilitation and presentation skills, including communication with executive leaders, global workstreams and site practitioners
  • Proven ability to lead through influence, negotiate priorities, manage change, and work effectively across diverse teams and management styles
  • Strong project management skills with ability to manage multiple workstreams, dependencies, decision and timelines
  • Experience supporting regulatory inspection or audit readiness while translating findings into sustainable business-process improvement
  • Strong Reliability Engineering experience
  • Solid understanding of GMP regulated quality systems and business processes
  • Proven skills and knowledge in problem solving techniques, continuous improvement initiatives, asset management, reliability, utilities and facilities operations
  • Ability to interpret and apply GLPs and GMPs
  • Excellent communication (verbal and written) and presentation skills
  • Dealing with and handling change with a good planning skill
  • Project management skills with the ability to handle multiple projects at one time
  • Good negotiating expertise; skilled in facilitation and collaboration, interacting successfully with variety of communication and working styles
  • Experience using creativity to define solutions, focus on innovation and process improvements with the ability to delegate and lead the work of others
  • Regulatory knowledge, experience in regulatory agencies' interactions; Knowledge of Engineering financial process, budget management and cost analysis

Benefits

  • Retirement and Savings Plan
  • Group medical, dental, vision
  • Life and disability insurance
  • Flexible spending accounts
  • Discretionary annual bonus
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models

Company overview

Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.

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