CrawlJobs Logo
Amgen Logo Amgen · IT - Software Development

Process Development Engineer

United States, Juncos · Job Posted June 17, 2026
Apply Position
Job Link Share

Job Description

In this vital role, you will provide advanced technical support for the development, optimization, scale-up, and transfer of manufacturing processes for biopharmaceutical products. This role operates as a technical contributor within cross-functional teams, applying engineering principles and scientific expertise to support process development activities through commercial manufacturing.

Job Responsibility

  • Lead process development, optimization, and scale-up activities for downstream manufacturing processes
  • Apply statistical tools and data analytics to evaluate process performance and support data-driven decision-making
  • Author and review technical reports, protocols, study plans, and development documentation
  • Support technology transfer activities between development, pilot, and manufacturing facilities
  • Collaborate with Manufacturing, Quality, Regulatory, Analytical Sciences, Supply Chain, and other functional teams to resolve technical issues
  • Support process validation and continued process verification activities
  • Identify opportunities for process improvements that enhance product quality, robustness, yield, and operational efficiency
  • Present technical findings and recommendations to project teams and leadership
  • Ensure compliance with applicable GMP, safety, and quality requirements.

Requirements

  • Master's degree in Engineering
  • OR Bachelor's degree of Engineering and 2+ years of relevant experience.

Nice to have

  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnology, Mechanical Engineering, or related scientific discipline
  • Experience supporting process development, manufacturing sciences, technical operations, or process engineering within the biotechnology, pharmaceutical, or related industry
  • Familiarity with GMP regulations and industry guidance
  • Experience with process monitoring, data visualization, and statistical software (e.g., JMP, Minitab, MATLAB, Python, Spotfire, or similar)
  • Strong technical writing and presentation skills
  • Proven ability to work effectively in cross-functional and matrixed environments
  • Combination of office and manufacturing floor environments
  • May require occasional off-shift support during critical manufacturing campaigns, technology transfers, or process troubleshooting activities
  • Ability to comply with all site safety, training, and GMP requirements.

What we offer

  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
  • 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.
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

Process Development Engineer

8 matching positions

Process Development Engineer

CK Group are recruiting for a Process Development Engineer, to join a global mat...
Location
Location
United Kingdom , Wigan
Salary
Salary:
28000.00 - 34000.00 GBP / Year
ckgroup.co.uk Logo
CK Group
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s or PhD background in Physical Science or Mechanical/Materials Engineering
  • Industrial manufacturing or process development experience is desirable
  • Full UK Driving licence
  • Hold entitlement to work in the UK
Job Responsibility
Job Responsibility
  • Support in developing our clients industrial manufacturing processes to produce glazing for the Automotive market
  • Fulltime
Read More
Arrow Right

Process Development Engineer

Process Development Engineer at Amgen Singapore Manufacturing. Amgen is one of t...
Location
Location
Singapore , Tuas
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience
  • 3+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries
  • At least 2 years’ experience with regulated environments (i.e. cGMP) required
  • In depth cell culture process knowledge, including single-use technologies and harvest technologies
  • Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
  • Possess basic understanding of regulatory and cGMP requirements
  • Able to apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements
  • Able to escalate relevant issues to project lead and line management
  • Independently motivated but also work well in team environment
  • Strong communication skills (technical writing and verbal communication/presentation)
Job Responsibility
Job Responsibility
  • Applies expertise in the successful coordination of multiple, complex, non-routine activities including tech transfer process qualification, process performance monitoring, floor support, troubleshooting of unit operations
  • Support/lead complicated investigations, providing concise communications to teams and leadership
  • Compile and analyze process data using tools such as excel, JMP, SIMCA to inform future decision-making and take predictive action
  • Author technical protocols, technical assessments, and product impact assessments
  • Verify data in technical reports, spreadsheets, and regulatory filings
  • Utilize strong written and verbal communication skills in technical writing and presentations
What we offer
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
Read More
Arrow Right

Process Development Engineer

Process Development Engineer at Amgen Singapore Manufacturing. Amgen is one of t...
Location
Location
Singapore , Tuas
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and/or 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience
  • 3+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries
  • At least 2 years’ experience with regulated environments (i.e. cGMP) required
  • In depth cell culture and/or purification process knowledge, including single-use technologies and harvest technologies
  • Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
  • Possess basic understanding of regulatory and cGMP requirements
  • Able to apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements
  • Able to escalate relevant issues to project lead and line management
  • Independently motivated but also work well in team environment
  • Strong communication skills (technical writing and verbal communication/presentation)
Job Responsibility
Job Responsibility
  • Applies expertise in the successful coordination of multiple, complex, non-routine activities including tech transfer process qualification, process performance monitoring, floor support, troubleshooting of unit operations
  • Support/lead complicated investigations, providing concise communications to teams and leadership
  • Compile and analyze process data using tools such as excel, JMP, SIMCA to inform future decision-making and take predictive action
  • Author technical protocols, technical assessments, and product impact assessments
  • Verify data in technical reports, spreadsheets, and regulatory filings
  • Utilize strong written and verbal communication skills in technical writing and presentations
What we offer
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
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

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