Manufacturing Process Engineer Job at Strategic Employment Partners (Irvine)

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

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