CrawlJobs Logo
Amgen Logo Amgen · Manufacturing

Engineer, Process Development

United States, Holly Springs 95914.00 - 116069.00 USD / Year · Job Posted March 25, 2026
Apply Position
Job Link Share

Job Description

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. In this role you will be a part of the Process Development Drug Substance Technology group at Amgen’s FleXBatch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.

Job Responsibility

  • Apply a fundamental understanding of Downstream bioprocessing to support biologics technology transfer, process validation, and plant start-up
  • Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
  • Ensure safety and compliance of process development activities
  • Provide process on floor process support as required
  • Provide support for regulatory filing, inspection, and other CMC activities
  • Apply fundamental scientific principles to Biopharmaceutical manufacturing processes (downstream purification)in the development of process improvements, facility adaptations, and new process operations
  • Provide technical and on-the-floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing
  • Support the GMP manufacturing process evaluations and investigations
  • Develop novel mammalian next generation technologies to increase yield, process robustness, and enable new unit operations

Requirements

  • High school diploma / GED and 8 years of process science or technology transfer experience
  • Associate’s degree and 6 years of process science or technology transfer experience
  • Bachelor’s degree and 4 years of process science or technology transfer experience
  • Master’s degree

Nice to have

  • 2 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing
  • Chromatography, ultrafiltration and normal flow filtration operations experience
  • Chemical engineering principles for the scale up of unit operations from bench scale to commercial scale
  • Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
  • Excellent written and verbal communication
  • Experience developing and managing team training workflows and strategy
  • Demonstrated ability to work under moderate direction
  • Able to analyze and interpret data
  • Be a self-starter with the ability to take on several projects at one time
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

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

Embedded Software Process & Development Engineer (Automotive Steering Systems)

We are looking for an Embedded Software Process & Development Engineer to suppor...
Location
Location
Sweden , Gothenburg
Salary
Salary:
Not provided
amaris.com Logo
Amaris Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in software development processes, including implementation and gap analysis (4 to 6 years)
  • Experience with ASPICE or similar automotive software process standards
  • Experience in requirements analysis for software functions in automotive systems
  • Experience in software design and development based on system requirements
  • Experience in designing and deriving test cases from software requirements
  • Experience in unit, integration, and system testing
  • Experience in debugging and troubleshooting software defects and performance issues
  • Experience in creating and maintaining detailed documentation of software designs, code, and testing procedures
  • Experience working in cross-functional teams and participating in design reviews
  • Bachelor’s or Master’s degree in computer science, engineering, or a related field
Job Responsibility
Job Responsibility
  • Implement software processes, such as ASPICE, by performing gap analysis and developing actions to close gaps
  • Coach the team on following software processes
  • Prepare reports and documentation for internal and external stakeholders
  • Analyze and understand requirements for software functions in steering systems
  • Design and implement software functions based on system requirements
  • Design and derive test cases from software requirements
  • Conduct unit testing, integration testing, and system testing to ensure reliability and functionality of software functions
  • Identify and resolve software defects, bugs, and performance issues using debugging tools and techniques
  • Create and maintain detailed documentation of software designs, code, and testing procedures
  • Collaborate with cross-functional teams, including hardware engineers, system engineers, and other software developers, to achieve project goals
What we offer
What we offer
  • International community bringing together 110+ different nationalities
  • Environment where trust has a central place: 70% of key leaders started their careers at the first level of responsibility
  • Robust training system with internal Academy and 250+ available modules
  • Vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
  • Opportunity to turn ideas into action and make a tangible impact on sustainability
  • WeCare Together program to design and lead projects that create real social or environmental impact
  • 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