Manufacturing Process Development Engineer Job at Aptiv plc (Krakow)

Working Student - Manufacturing Process Development

Our department 'Development of Electric Drive Systems, Power Electronics, and Tr...

Location

Germany , Kassel

Salary:

Not provided

Volkswagen AG

Expiration Date

Until further notice

Requirements

Master’s degree students (or advanced Bachelor’s students with at least 90 ECTS) in Electrical Engineering, Mechanical Engineering, or similar fields
Good to very good academic performance
Advanced CAD skills required, along with proficiency in MS Office
Prior experience with design software, project execution, and electric machines is desirable
German and English language skills at B2 level
Valid Class B driver’s license

Job Responsibility

Designing tools and equipment for manufacturing process development
Supporting through research, feasibility studies, and material analysis
Conducting, monitoring, documenting, and evaluating test series
Independently executing small work packages within projects
Assisting in various pre-development projects

Parttime

Process Engineer, Manufacturing Science & Technology

As we move our cell therapy programs through late-stage development toward BLA s...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

B.S. with 3 + years or M.S. with 2-3 years' experience within biologics process development, MSAT or manufacturing under cGMP processes or PhD degree
Previous experience and working knowledge of T-cells or immunological cell therapies
Experience with cell therapy manufacturing scale up, technology transfer, and process development and optimization is required
Experience supporting late-stage MSAT activities, including process characterization, PPQ planning/execution, scale-up/scale-out strategies, and continued process verification
Direct involvement in BLA-enabling MSAT deliverables such as Module 3 process descriptions, validation packages, tech transfer documentation, and inspection readiness strongly preferred
Good working knowledge in cGMP manufacturing of biological process and ICH regulations
Strong written and verbal communication skills
Highly organized and efficient
Able to work independently
Strong problem-solving skills

Job Responsibility

Support technology transfer of mature, optimized processes to CMOs for clinical and late-phase cGMP manufacturing, ensuring readiness for PPQ and commercial-scale operations
Provide manufacturing oversight at CMOs, including person-in-plant support, review of manufacturing performance, and real-time issue escalation to maintain phase-appropriate control strategies
Execute process development and characterization studies, generate high-quality protocols and reports, and present data to cross-functional teams to inform PPQ planning and BLA Module 3 content
Ensure timely and accurate data capture, supporting data integrity requirements for late-stage filings, validation packages, and regulatory inspections
Maintain all training requirements in a compliant state, aligning with expectations for late-stage manufacturing and inspection readiness
Support phase-appropriate cell therapy processes using QbD principles, including identification of CPPs/CMAs and contributing to control strategy refinement for BLA submission
Identify and evaluate new technologies that enhance scalability, robustness, cost efficiency, and process consistency in preparation for commercial readiness
Provide ongoing oversight of CMO operations, including batch record and testing documentation review, data trending, and deviation/CAPA support consistent with PPQ and late-stage expectations
Coordinate internal and external activities related to patient material and product logistics, ensuring compliant chain-of-identity/chain-of-custody processes critical for pivotal trial operations
Support MSAT planning for development and validation materials, maintaining inventory and coordinating procurement to enable process characterization and PPQ readiness

What we offer

health and retirement, PTO, and stock option plans

Fulltime

Senior Manufacturing Process Engineer

Ready to join a team of visionaries who is dedicated to solving one of humankind...

Location

Germany , Munich

Salary:

Not provided

Climeworks

Expiration Date

Until further notice

Requirements

Degree in process engineering, manufacturing engineering, mechanical engineering, materials science, or similar
5-10 years of experience in a manufacturing environment including significant experience with start-up phases and successful delivery of commercial products
Experience with continuous manufacturing lines including powder handling processes (HSE regulations and ATEX requirements)
Logic-driven, experienced with both process modeling approaches (heat and mass transfer, etc.) as well as structured risk-identification and problem-solving tools (e.g., process FMEA, 5 Whys, Fishbone)
Take initiative, are results-driven without missing important details, and are hands-on throughout the full development cycle—from lab to high-level evaluations
Collaborate easily across teams, communicate clearly, and enjoy leading both in-house and external projects
Fluent in English
At least B1-level proficiency in German
Knowledge of French is an advantage
Open to frequent travel (up to 60%, primarily between the Munich and Zurich areas)

Job Responsibility

Manufacturing process expert: Climeworks’ core expert in the process operation of novel manufacturing lines for sorbent filter production, during development, startup, and operation
Own all aspects of manufacturing process engineering to produce new sorbent filter material (working with manufacturing engineers and product owners): Understand process parameters & product impact
Evaluate and tune parameter ranges used in equipment purchases and in startup
Lead manufacturing process ramp-up, troubleshooting, and root cause analysis
Lead and own process FMEAs before, during, and after the startup phase
Ensure good documentation, training, and knowledge transfer
Cross-Functional Collaboration: Collaborate closely with internal experts in R&D, characterization/quality, product design, and sorbent/process development to ensure manufacturing process parameters lead to a guaranteed high-quality sorbent module product, and support the development of new testing methods
External partnerships & technical leadership: Act as a key technical expert in collaborations with external partners, ensuring DAC-specific requirements for sorbent filters manufacturing are met, including by being on-site to monitor operations when needed
Team player: Where needed, support lab-scale manufacturing in R&D, and new concept evaluation, for future-oriented DAC solutions

Process Development Senior Engineer

Process Development Senior Engineer for Amgen Singapore Manufacturing. Amgen is ...

Location

Singapore , Tuas

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of directly related experience
Bachelor’s degree and 4 years of directly related experience
Diploma and 8 years of directly related experience
6+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries
At least 4 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
Good understanding of process characterization and process scale up to resolve technical issues observed during transfer / manufacturing at large scale.
Experienced in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
Experienced in Technology Transfer of new process and technology to commercial site.

Job Responsibility

Assume a Subject Matter Expert role within ASM Process Development for cell culture and/or purification commercial process support.
Act as Drug Substance Team Leader within the global Product Development Team (PDT)
providing stewardship of product lifecycle and process improvement.
Lead complicated investigations independently, providing concise communications to teams and leadership
Integrate trends, data and information into plans, deliverables and recommendations
Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives.
lead productivity projects, process optimization, and product life cycle management.
Collaborate with cross-functional teams and network drug substance teams to resolve process challenges by applying advanced technical principles and concepts for troubleshooting.
Apply best practices to leverage data for more proactive and predictive approaches.
Support regulatory filings, audits and inspection, and other CMC activities (e.g author and review regulatory submissions and responses to questions as required).

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

Process Development Engineer

Process Development Engineer at Amgen Singapore Manufacturing. Amgen is one of t...

Location

Singapore , Tuas

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

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

Process Development Engineer

Process Development Engineer at Amgen Singapore Manufacturing. Amgen is one of t...

Location

Singapore , Tuas

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

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

Manufacturing Process Engineer II

At Batesville, you will be a part of a dynamic team committed to excellence and ...

Location

United States , Vicksburg

Salary:

Not provided

Batesville Canada ULC

Expiration Date

Until further notice

Requirements

Bachelor’s degree (B.S./B.A.) or equivalent from a college or university in Engineering or related field
Minimum of 2 years related engineering experience and/or training
with an emphasis on manufacturing environment
Experience in AutoCAD and Info View
Business acumen with experience relating projects to growth and profitability
Ability to compile, display and analyze data in a logical format and to use the data to develop solutions
Solid organizational skills and ability to operate in a fast-paced environment with multiple priorities

Job Responsibility

Build relationships across all levels to understand ongoing operational issues and lead improvement and sustainability efforts
Design, develop, and implement process improvements and to control usage and reduce scrap
Ensure product flow is optimized by reducing WIP and improving productivity
Applies statistical process control (SPC) methods and quality design and control tools (PFMEA, Control Plan, DOE, etc.) for analyzing data to evaluate the current process and process changes
Support implementation of corrective actions to solve production/quality issues
Cash Forecasting and Analysis: Prepare accurate and reliable cash flow forecasts, analyze variances, and provide insights to support strategic decision-making
Other duties may be assigned

What we offer

Comprehensive medical, dental and vision insurance, as well as prescription coverage, short-term disability, Employee Assistance Program (EAP), and more offered after 90 calendar days
Generous 401K Matching Program
Opportunities for development and advancement

Fulltime

Manufacturing Test Development Engineer

Cricut (Malaysia) Sdn. Bhd. is seeking an experience and versatile Mfg. Software...

Location

Malaysia , Senai, Johor

Salary:

Not provided

Cricut

Expiration Date

Until further notice

Requirements

Diploma/Degree in EE/Mechanical/Mechatronics/Software Engineering or equivalent
4 to 6 years of related experience in the field of software development and fixture development
4 to 6 years of experience in desktop (stand-alone), and web-based software development
Experience in testing IOS and Android applications
Experience in testing software interacting with hardware
Experience in working with manufacturers to implement and integrate software to test stations for calibration and testing hardware functions
Experience in investigating and analysing logs, debugging software issues, finding root causes, and recommending mitigation plans
Experience in analysing logs and debugging using browser debugging tools
Knowledge of basic mechanical design, power, electronics control circuit, sensors, robotics
Practical day-to-day experience using a 3D solid modelling CAD package is essential with Lean manufacturing principals

Job Responsibility

Working alongside with product development teams to validate the Software designed by Cricut TDE
Work collaboratively across departments, providing early involvement support such as Design for Testability (DFT), RFQ, Equipment /test schedules and process test input for new product designs during NPI stage
Daily assignments will be testing the software and report back the bugs to the TDE back in head quarters in US
Be responsible for testing new hardware products & applications and communicating with development teams
Develop and execute an organized test plan to release high quality products to market and production lines on schedule

What we offer

Outstanding medical, dental, vision, and retirement benefits
pet insurance
401K match
life insurance
incentive programs
paid time off
on-site massages
phenomenal work-life balance
employee discounts

Fulltime

Manufacturing Process Development Engineer

Aptiv plc

Location:
Poland , Krakow

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 20, 2026

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Working Student - Manufacturing Process Development