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Process Engineer - Tech Transfer & Process Improvement
$100,000–$149,950 year
On-site · Teterboro, New Jersey, United States
Job Summary
Manufacturing Engineer III at Thermo Fisher Scientific focuses on optimizing production processes, leading technology transfer efforts, and driving continuous improvement in regulated environments. Responsibilities include managing process improvement and tech transfer projects, providing technical expertise for new product introductions and deviation investigations, collaborating with Quality, Production, and other departments to ensure regulatory compliance, and driving cost reductions and manufacturing capability enhancements.
Required Qualifications
- Advanced Degree plus 3 years of experience, or bachelor's degree plus 5 years of experience in manufacturing engineering in regulated industries (pharmaceutical, medical device, or similar)
- Lean Six Sigma certification preferred
- Strong knowledge of GMP, ISO standards, and regulatory requirements
- Experience with design of single-use-systems, PUPSIT assemblies, aseptic filling technologies, technology transfers, and change control management
- Proficient in statistical analysis and continuous improvement methodologies
- Strong project management skills and ability to work with cross-functional teams
- Demonstrated success implementing process improvements and cost reduction initiatives
- Experience with risk assessment methodologies and root cause analysis
- Knowledge of lean manufacturing principles and tools
- Strong written and verbal communication skills
- Ability to work in a dynamic manufacturing environment
- Cleanroom experience when required
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