Process Engineer III

Position Summary

Experienced Process Engineer III responsible for leading technology transfer, manufacturing process support, and strategic engineering projects within a GMP/ISO 9001 regulated environment. Provides technical leadership for process development, equipment qualification, process validation, and manufacturing optimization while supporting new product introductions and continuous improvement initiatives. Collaborates with cross-functional and global engineering teams to ensure efficient, compliant, and reliable manufacturing operations.

Key Responsibilities

• Lead technology transfer activities and support manufacturing process stabilization across multiple products and manufacturing sites.
• Manage engineering projects while providing technical support for day-to-day manufacturing operations in a regulated environment.
• Develop and execute process and equipment qualification/validation (IQ/OQ/PQ) protocols and support process validation activities.
• Prepare engineering documentation, including change controls, test protocols, validation reports, risk assessments, and technical documentation.
• Drive continuous improvement initiatives by applying Lean manufacturing principles, statistical process control (SPC), and data analysis to improve process efficiency, quality, and compliance.
• Support new product introductions by contributing to process design, scale-up, and manufacturing implementation.
• Collaborate with cross-functional teams, including Manufacturing, Quality, R&D, Validation, and Global Engineering, to execute strategic projects and resolve technical issues.
• Mentor junior engineers, provide technical guidance, and promote engineering best practices and standardization.
• Identify and implement process improvements while ensuring compliance with GMP, ISO 9001, and company quality standards.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 5–7 years of engineering experience in biopharmaceutical, pharmaceutical, biologics, medical device, or other life sciences manufacturing environments.
• Hands-on experience in GMP and/or ISO 9001 regulated manufacturing with knowledge of process engineering, technology transfer, equipment qualification, and process validation.
• Strong technical expertise in Tangential Flow Filtration (TFF), Statistical Process Control (SPC), automation, Lean manufacturing, process optimization, and data analysis.
• Proficiency with SolidWorks/CAD, Microsoft Office, and engineering documentation systems.
• Demonstrated success managing multiple engineering projects, leading cross-functional teams, and solving complex manufacturing challenges with minimal supervision.
• Excellent communication, project management, and analytical skills with a commitment to continuous improvement, quality, and operational excellence.