Senior Process Engineer

About the role

The Senior Process Engineer will lead process development, optimization, and validation in a regulated manufacturing environment. You will drive continuous improvement, ensure compliance with quality and regulatory standards, and work closely with R&D, Quality, Operations, and Supply Chain to deliver scalable, cost‑effective manufacturing solutions.

Key responsibilities

• Provide technical and sustaining engineering support for manufacturing operations.
• Recommend and implement equipment and process modifications to improve quality, efficiency, and yield.
• Integrate equipment and material capabilities to meet target specifications.
• Review product development requirements for processing compatibility, cost, and schedule.
• Collaborate with design and development teams to ensure process‑design alignment.
• Lead innovation, development, and optimization of new manufacturing concepts and procedures for transfer to production.
• Develop statistical process control methods and measurement systems.
• Ensure all processes and procedures comply with FDA QSR, ISO 13485, and GMP regulations.

Required profile

• Bachelor’s degree in Engineering with at least 4 years of relevant experience, or Master’s with 2 years, or PhD with no experience required.
• Proven experience in regulated manufacturing environments.
• Strong background in process characterization, root‑cause analysis, and scalable manufacturing solutions.

Required skills

• Lean Manufacturing
• Six Sigma (Green Belt or Black Belt)
• Advanced statistical analysis (DOE, SPC, MSA, process capability studies)
• Automation and digital manufacturing
• Equipment qualification & validation (IQ, OQ, PQ)
• Risk management tools (FMEA, Fault Tree Analysis)
• Regulatory knowledge (FDA QSR, ISO 13485, GMP)
• Design for Manufacturability