Process Engineer II

We are seeking a Process Development Engineer to support the development, qualification, and manufacturing readiness of pharmaceutical-coated medical devices. This role is focused on process validation, process optimization, and manufacturing line implementation within a regulated environment.

Key Responsibilities:

• Execute and support process qualification activities (IQ/OQ/PQ).
• Lead process characterization and validation studies to establish robust manufacturing processes.
• Drive continuous process improvements to optimize quality, yield, and production efficiency.
• Support equipment selection, qualification, and manufacturing line validation activities.
• Collaborate cross-functionally with R&D, Quality, Manufacturing, and Operations teams to ensure process and product requirements are met.

Required Qualifications:

• Bachelor's degree in Engineering or a related technical discipline.
• 2 to 5 years of experience in process development, manufacturing engineering, or process validation.
• Working knowledge of IQ/OQ/PQ, process characterization, and manufacturing validation methodologies.
• Experience utilizing engineering tools to analyze, develop, and improve manufacturing processes.
• Strong analytical and technical problem-solving skills with a data-driven approach.

Preferred Qualifications:

• Experience in medical device, pharmaceutical, or other regulated manufacturing environments.
• Knowledge of statistical process control (SPC) and data analysis techniques.
• Experience with equipment development, qualification, and technology transfer activities.