Process Development Engineer Job at CK Group (Wigan)

Process Development Engineer

In this vital role, you will provide advanced technical support for the developm...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

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

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.

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.

Fulltime

Embedded Software Process & Development Engineer (Automotive Steering Systems)

We are looking for an Embedded Software Process & Development Engineer to suppor...

Location

Sweden , Gothenburg

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

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

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

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

Sr. Engineer Process Development

The Senior Engineer, Process Development will provide process development suppor...

Location

Ireland , Dun Laoghaire

Salary:

70408.90 - 95259.10 EUR / Year

Amgen

Expiration Date

Until further notice

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

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

Npi Dfm Process Development Engineer

Teradyne’s Semiconductor Test Division develops the world’s leading equipment fo...

Location

United States , North Reading; Agoura Hills; Deer Park

Salary:

89300.00 - 189500.00 USD / Year

Teradyne

Expiration Date

Until further notice

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

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

medical
dental
vision
Flexible Spending Accounts
retirement savings plans
life and disability insurance
paid vacation & holidays
tuition assistance programs

Fulltime

Sr Engineer, Process Development

Join Amgens Mission of Serving Patients. At Amgen, if you feel like you are part...

Location

United States , Holly Springs

Salary:

115494.60 - 156257.40 USD / Year

Amgen

Expiration Date

Until further notice

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

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

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

NPI Test Process Development Engineer

Teradyne's Semiconductor Test Division develops the world's leading equipment fo...

Location

United States , Agoura Hills

Salary:

98300.00 - 157300.00 USD / Year

Teradyne

Expiration Date

Until further notice

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

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

Medical, dental, vision
Flexible Spending Accounts
Retirement savings plans
Life and disability insurance
Paid vacation & holidays
Tuition assistance programs

Fulltime

Npi Test Process Development Engineer

Teradyne’s Semiconductor Test Division develops the world’s leading equipment fo...

Location

United States , North Reading; Agoura Hills; Deer Park

Salary:

76600.00 - 122500.00 USD / Year

Teradyne

Expiration Date

Until further notice

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

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

medical
dental
vision
Flexible Spending Accounts
retirement savings plans
life and disability insurance
paid vacation & holidays
tuition assistance programs

Fulltime

Npi Dfm Process Development Engineer

We are the global test and automation specialists, powering next-generation tech...

Location

United States , North Reading; Agoura Hills; Deer Park

Salary:

76600.00 - 122500.00 USD / Year

Teradyne

Expiration Date

Until further notice

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

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

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

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Process Development Engineer

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