CrawlJobs Logo
Amgen Logo Amgen · Manufacturing

Engineer - Process Development

United States, New Albany 95914.00 - 116069.00 USD / Year · Job Posted March 20, 2026
Apply Position
Job Link Share

Job Description

Join Amgen’s Mission of Serving Patients. In this role the Engineer will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP Commercial GMP Operations at AOH. The position is a key role in the Process Development group and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, validation, maintenance and alteration of systems, facilities and/or processes. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, optimization, scale up or manufacturing support projects.

Job Responsibility

  • Support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP Commercial GMP Operations at AOH
  • Support the Technical Transfer of the Amgen product portfolio to AOH
  • Provision of technical operations support for the continuous improvement of packaging lines capacity and performance, and advisory of technical improvement projects
  • Act as a subject matter expert for FDP GMP operations at AOH, and primarily as technical support for new process equipment and technology
  • Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the AOH manufacturing lines by analyzing, designing, and implementing manufacturing and business process improvements
  • Build a network of FDP expertise within AOH and across other Amgen commercial operations for product assembly, label and packaging

Requirements

  • Master’s degree
  • Bachelor’s degree and 2 years of working in a GMP regulated environment
  • Associate’s degree and 6 years of working in a GMP regulated environment
  • High school diploma / GED and 8 years of working in a GMP regulated environment experience

Nice to have

  • Track record of contributing to multi-functional projects
  • Strong team work, excellent interpersonal and communication skills
  • Experience with devices/combination products and the associated manufacturing process
  • Experience of working with equipment suppliers
  • Ability to work in a highly regulated and ever changing industry
  • Ability to learn and rapidly adapt to new requirements in a fast moving environment
  • An Operational Excellence approach to work product – driving rapid results
  • A passion to deliver an excellent work product and develop others with an infective positive attitude!

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, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models, including remote and hybrid work arrangements, where possible
Amgen - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Engineer - Process Development

8 matching positions

Engineer - Process Development

In this vital role you will be responsible for supporting process development an...
Location
Location
United States , Cambridge
Salary
Salary:
88281.00 - 119439.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master's degree
  • Bachelor's degree and 2 years of Engineering or Operations experience
  • Associate's degree and 6 years of Engineering or Operations experience
  • High school diploma / GED and 8 years of Engineering or Operations experience
Job Responsibility
Job Responsibility
  • Evaluate, select and execute standard experimental, modeling and engineering techniques for process optimization, characterization, and scale up of synthetic active pharmaceutical ingredients in state-of-the-art facilities
  • Initiate and complete technical tasks in lab, kilo/pilot plant, and manufacturing environments
  • Author documents for process understanding, transfer, risk assessment, facility fit, and development/characterization
  • Function as a technical expert to equipment or systems regarding troubleshooting operations
  • Frequently become actively involved in daily production or development operations when required to meet schedules or to resolve complex problems
  • Routinely monitor manufacturing processes for performance indicators and operations
  • Suggest problem resolution, provide troubleshooting guidance and recommend process improvements
  • Apply engineering principles and statistical analysis, including design of experiments, in order to solve processing issues and evaluate opportunities for process improvements
  • Communicate and collaborate with Manufacturing, Process Development, and Quality departments
  • Contribute to key regulatory and quality activities such as non-conformance, process performance qualification and continued process verification
What we offer
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
  • Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right
New

Sr. Engineer Process Development

The Senior Engineer, Process Development will provide process development suppor...
Location
Location
Ireland , Dun Laoghaire
Salary
Salary:
70408.90 - 95259.10 EUR / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Science, Engineering, Quality or a related discipline and 5 years of directly related experience
  • OR Master's degree and 3 years of directly related experience
  • OR Associate's degree and 10 years of directly related experience
  • Knowledge of cGMP and applicable global regulatory requirements
  • Strong understanding of aseptic manufacturing technologies and cGMP expectations
  • Ability to apply engineering and scientific principles to formulation, single-use systems and filling process design and implementation
  • Demonstrated problem-solving skills with strong written, verbal and technical communication skills
  • Ability to work effectively in cross-functional teams in a highly regulated manufacturing environment
Job Responsibility
Job Responsibility
  • Provide filling characterisation support, including filling recipe development, protocol development, protocol execution, data analysis and technical reporting
  • Apply process development expertise to sterile drug product processing, including process characterisation, filling operations and single-use systems (SUS)
  • Support commercial drug product manufacturing through technical evaluation of nonconformances (NCs), corrective and preventive actions (CAPAs), deviations/exceptions and technology transfer activities
  • Troubleshoot drug product processing technologies and equipment, using data-driven analysis and visualisation to determine root cause and recommend effective corrective actions
  • Lead or support deviation/exception resolution, root cause analysis, risk assessments and CAPA development/implementation for drug product operations
  • Lead and contribute to cross-functional and cross-site teams, providing technical recommendations to management and helping advance complex projects to completion
  • Partner with Manufacturing, Operations, Engineering, Quality, Validation, external vendors and other support functions to provide coordinated technical support to manufacturing
  • Ensure site activities meet safety expectations, customer quality requirements and applicable regulatory expectations, including FDA, EU and other international standards
  • Review and approve process validation protocols, assessments and quality system documentation, as required
  • Contribute to product quality assessments, process flow documentation and validation strategies
  • Fulltime
Read More
Arrow Right

Npi Dfm Process Development Engineer

Teradyne’s Semiconductor Test Division develops the world’s leading equipment fo...
Location
Location
United States , North Reading; Agoura Hills; Deer Park
Salary
Salary:
89300.00 - 189500.00 USD / Year
teradyne.com Logo
Teradyne
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree in Engineering (Manufacturing, Mechanical preferred)
  • 5+ years in printed circuit board assembly and manufacturing
  • Knowledge of PCBA processes (solder paste printing, SMT placement, reflow soldering, aqueous cleaning, automated inspection, ESD principles)
  • Familiarity with IPC-610, IPC-7711/7721, J-STD
  • Experience with PC layout/design review software (Cadence Allegro, Valor)
  • EMS/CM supplier collaboration desirable
  • Able to travel ~10%
  • periodic calls with Asian teams and suppliers
  • This position is not eligible for visa sponsorship
  • US Citizen or U.S. Permanent Resident, Asylee, Refugee or otherwise lawfully admitted under an amnesty program
Job Responsibility
Job Responsibility
  • Collaborate with Hardware Design on New Product initiatives, influencing Printed Circuit Board Assembly product development with Design for Manufacturability principles
  • Drive failure analysis for electrical components and PCBA solder defects
  • Develop and support Teradyne PCBA Design for Manufacturability guidelines and assembly best practices
  • drive improvements and updates to NPI process documentation
  • Support Operations NPI objectives by executing component assessment, manufacturing process development, and fault-down activities for printed circuit board assemblies
  • Work with contract manufacturing teams to support new PCBA initial builds, experiments, and failure analysis
  • Lead NPI Lessons Learned activities, integrating feedback from high-volume manufacturing into NPI processes
What we offer
What we offer
  • medical
  • dental
  • vision
  • Flexible Spending Accounts
  • retirement savings plans
  • life and disability insurance
  • paid vacation & holidays
  • tuition assistance programs
  • Fulltime
Read More
Arrow Right

Sr Engineer, Process Development

Join Amgens Mission of Serving Patients. At Amgen, if you feel like you are part...
Location
Location
United States , Holly Springs
Salary
Salary:
115494.60 - 156257.40 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma / GED and 10 years of biologics process development or commercial-scale technology transfer and technical support experience OR Associate degree and 8 years of biologics process development or commercial-scale technology transfer and technical support experience OR Bachelor degree and 4 years of biologics process development or commercial-scale technology transfer and technical support experience OR Master degree and 2 years of biologics process development or commercial-scale technology transfer and technical support experience OR Doctorate degree
Job Responsibility
Job Responsibility
  • Apply fundamental scientific principles to Biopharmaceutical manufacturing processes (Upstream and Harvest) in the development of process improvements, facility adaptations, and new process operations
  • Provide technical leadership and on-the-floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing
  • Support the GMP manufacturing process tech transfer, evaluations, investigations, innovation and product life cycle management
  • Provide support for regulatory filing, inspection, and other CMC activities
  • Develop novel mammalian next generation technologies to increase yield, process robustness, and enable new unit operations
What we offer
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, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

NPI Test Process Development Engineer

Teradyne's Semiconductor Test Division develops the world's leading equipment fo...
Location
Location
United States , Agoura Hills
Salary
Salary:
98300.00 - 157300.00 USD / Year
teradyne.com Logo
Teradyne
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree in Engineering (Manufacturing, Mechanical or Electronics preferred)
  • 5+ years in printed circuit board assembly testing
  • Proficiency with In-Circuit Test development on platforms such as Teradyne Test Station or equivalent
  • Experience with ICT Fixture development and fabrication process
  • Proficient in measurement techniques and process controls for yield analysis, statistics CP/CPK and normal distributions a plus
  • Experience with PC layout/design review software (Cadence Allegro, Valor)
  • EMS/CM supplier collaboration desirable
  • Experience with scripting language (Perl, Python, etc.), Visual Basic / C# .NET is a plus
  • Able to travel ~10%
  • periodic calls with Asian teams and suppliers
Job Responsibility
Job Responsibility
  • Integrate with Hardware Development groups from across the company to develop structural test strategies for printed circuit boards at each quality gate in production including flying probe test and in-circuit test platforms
  • Collaborate with various functional skills (SW/HW/Pilot Lines/Operations/etc.) in overall printed circuit board, higher level assembly and system level test development planning and execution
  • Influence the printed circuit board component selection, schematic and physical layout processes to ensure project objectives are met in the overall product quality, validation and testing strategy
  • Drive the contract manufacturing process for Flying Probe and ICT development including fixture and program development quotes, schedules, documentation, validation and release to production
  • Innovate methods and means of improving quality gate processes, efficiencies and best practices
What we offer
What we offer
  • Medical, dental, vision
  • Flexible Spending Accounts
  • Retirement savings plans
  • Life and disability insurance
  • Paid vacation & holidays
  • Tuition assistance programs
  • Fulltime
Read More
Arrow Right

Npi Test Process Development Engineer

Teradyne’s Semiconductor Test Division develops the world’s leading equipment fo...
Location
Location
United States , North Reading; Agoura Hills; Deer Park
Salary
Salary:
76600.00 - 122500.00 USD / Year
teradyne.com Logo
Teradyne
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree in Engineering (Manufacturing, Mechanical or Electronics preferred)
  • 2+ years in printed circuit board assembly testing
  • Proficiency with In-Circuit Test development on platforms such as Teradyne Test Station or equivalent
  • Experience with ICT Fixture development and fabrication process
  • Proficient in measurement techniques and process controls for yield analysis, statistics CP/CPK and normal distributions a plus
  • Experience with PC layout/design review software (Cadence Allegro, Valor)
  • Experience with scripting language (Perl, Python, etc.), Visual Basic / C# .NET is a plus
  • Able to travel ~10%
  • periodic calls with Asian teams and suppliers
  • local to position location
Job Responsibility
Job Responsibility
  • Integrate with Hardware Development groups from across the company to develop structural test strategies for printed circuit boards at each quality gate in production including flying probe test and in-circuit test platforms
  • Collaborate with various functional skills (SW/HW/Pilot Lines/Operations/etc.) in overall printed circuit board, higher level assembly and system level test development planning and execution
  • Influence the printed circuit board component selection, schematic and physical layout processes to ensure project objectives are met in the overall product quality, validation and testing strategy
  • Drive the contract manufacturing process for Flying Probe and ICT development including fixture and program development quotes, schedules, documentation, validation and release to production
  • Innovate methods and means of improving quality gate processes, efficiencies and best practices
What we offer
What we offer
  • medical
  • dental
  • vision
  • Flexible Spending Accounts
  • retirement savings plans
  • life and disability insurance
  • paid vacation & holidays
  • tuition assistance programs
  • Fulltime
Read More
Arrow Right

Npi Dfm Process Development Engineer

We are the global test and automation specialists, powering next-generation tech...
Location
Location
United States , North Reading; Agoura Hills; Deer Park
Salary
Salary:
76600.00 - 122500.00 USD / Year
teradyne.com Logo
Teradyne
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree in Engineering (Manufacturing, Mechanical preferred)
  • 2+ years in printed circuit board assembly and manufacturing
  • Knowledge of PCBA processes (solder paste printing, SMT placement, reflow soldering, aqueous cleaning, automated inspection, ESD principles)
  • Familiarity with IPC-610, IPC-7711/7721, J-STD
  • Experience with PC layout/design review software (Cadence Allegro, Valor)
  • Able to travel ~10%
  • Periodic calls with Asian teams and suppliers
Job Responsibility
Job Responsibility
  • Collaborate with Hardware Design on New Product initiatives, influencing Printed Circuit Board Assembly product development with Design for Manufacturability principles
  • Drive failure analysis for electrical components and PCBA solder defects
  • Develop and support Teradyne PCBA Design for Manufacturability guidelines and assembly best practices
  • Drive improvements and updates to NPI process documentation
  • Support Operations NPI objectives by executing component assessment, manufacturing process development, and fault-down activities for printed circuit board assemblies
  • Work with contract manufacturing teams to support new PCBA initial builds, experiments, and failure analysis
  • Lead NPI Lessons Learned activities, integrating feedback from high-volume manufacturing into NPI processes
What we offer
What we offer
  • Discretionary bonus based on financial performance
  • Medical
  • Dental
  • Vision
  • Flexible Spending Accounts
  • Retirement savings plans
  • Life and disability insurance
  • Paid vacation and holidays
  • Tuition assistance programs
  • Fulltime
Read More
Arrow Right

Development Process Engineer

The Development Process Engineer is an essential role that uses systems and soft...
Location
Location
Poland , Krakow
Salary
Salary:
Not provided
borgwarner.com Logo
BorgWarner
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Masters or Engineering degree in Electrical/Electronic/Mechatronics or similar
  • Demonstrated Systems Engineering, Software Engineering, or Software Quality Assurance competency
  • Experience in ASPICE or CMMI
  • Good communication, leadership skills and self-motivated
  • Working knowledge of ISO26262 (Functional Safety) and ISO21434 (Cybersecurity) is an asset
  • Fluency in English is required. German and/or French would be an advantage
Job Responsibility
Job Responsibility
  • Proactively analyzes systems/software process deployments, identifies opportunities for improvement and develops solutions
  • Uses demonstrated systems/software experience and lessons learned to drive engineering project teams to achieve their quality goals and leads project teams in the usage of evolving Processes, Methods and Tools
  • Develops training curriculum and transfers knowledge of the BorgWarner EDF process, roles, and responsibilities to the engineering teams
  • Implements the quality assurance plan as defined by the QA (Quality Assurance) group on each project assigned
  • Works closely with the engineering teams to monitor performance of the systems and software processes
  • Performs assessments of work products and adherence to process
  • Performs assessment of work product review effectiveness. Makes recommendations on improvements
  • Creates and maintains a quality assurance dashboard and metrics for reporting to the project and matrix organization
  • Raises and tracks Quality Assurance (QA) findings to closure
  • Performs random checks of document consistencies and accuracy
  • Fulltime
Read More
Arrow Right