Sr. Process Engineer

Sr. Process Engineer

Work Location: Los Angeles County, California

Summary:

Seeking a highly skilled Sr. Process Engineer to lead multi-product project execution, technology transfer, and manufacturing support. This role involves collaboration with global engineering teams and focuses on process development, validation, and continuous improvement within regulated manufacturing environments.

Responsibilities:

• Direct and execute projects involving technology transfer, process development, validation, and production line enhancements.
• Collaborate with international engineering teams to facilitate the transfer of manufacturing equipment and processes to external manufacturing sites.
• Oversee process development and support activities at contract manufacturing locations.
• Develop and implement qualifications for processes, materials, and equipment, ensuring compliance with industry standards.
• Create and maintain comprehensive engineering documentation, including specifications, drawings, protocols, and technical reports.
• Review, standardize, and harmonize existing manufacturing process documentation for consistency and compliance.
• Serve as a subject matter expert in filtration and bioprocessing manufacturing systems, driving innovation and scalability.
• Identify, recommend, and implement process improvements while mentoring junior team members and supporting best practice training.

Qualifications:

• Bachelor’s degree in Engineering required.
• 7–10 years of experience in medical devices or related fields.
• Hands-on expertise in process validation, equipment qualification, and technology transfer between international sites.
• Proficiency in data analysis, automation, and use of statistical tools for process optimization.
• Experience with filtration systems such as Hollow Fiber and Flat Sheet Membranes.
• Strong knowledge of ISO 9001, ISO 13485, or GMP manufacturing standards.
• Skilled in SolidWorks/CAD, MS Office, and electronic file management systems.
• Familiarity with single-use systems, sterilization techniques, and lean manufacturing principles preferred.
• Demonstrated ability to lead cross-functional teams and manage projects in a matrixed environment.
• High level of personal integrity, adaptability, and leadership by example.
• Ability to independently define and execute projects, provide technical direction, and communicate effectively with senior leadership.
• Experience balancing plant support with project execution and delegating tasks for team development.
• Comfortable working in cleanroom and laboratory environments, with exposure to chemicals, mechanical systems, and occasional electrical hazards.
• Ability to lift up to 50 lbs and operate in areas with noise and vibration as required.

Published Category: Manufacturing & Technical Operations