Job Purpose:

The Quality Engineer supports aseptic manufacturing operations by executing quality system activities, participating in facility and equipment commissioning, and driving process improvements. This role works cross-functionally with Manufacturing, Engineering, MS&T, and Quality to ensure compliance with cGMP requirements while supporting both development and commercial manufacturing programs.

This position includes hands-on involvement in cleanroom environments and requires strong technical, analytical, and documentation skills.

Essential Duties and Responsibilities:

· Execute and support cGMP operations and project-based work, including commissioning activities, process studies, and quality system initiatives

· Participate directly in facility and equipment commissioning activities, including field execution, documentation, and coordination with engineering and operations teams

· Support and execute process and product development studies, including data collection, analysis, and documentation

· Contribute to technology transfer and scale-up activities, supporting successful transition from development to manufacturing

· Participate in cleanroom and controlled environment activities, including:

· Supporting airflow visualization (smoke studies)

· Assisting with cleanroom setup, readiness, and operational support

· Execute and support CAPA-related projects, including root cause analysis, implementation of corrective and preventive actions, and effectiveness checks

· Support deviations, investigations, and change controls through data gathering, documentation, and implementation of actions

· Ensure all work is documented in accordance with cGMP requirements, maintaining accuracy, completeness, and data integrity

· Collaborate cross-functionally with Manufacturing, Engineering, MS&T, and Quality teams to support facility startup, operational readiness, and continuous improvement initiatives

· Participate in risk assessments and support mitigation activities related to processes, equipment, and cleanroom environments

· Contribute to inspection readiness efforts, including documentation support and response to audit observations

· Identify and support process and operational improvements across development and manufacturing activities

Education / Experience:

· Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or a related field.

· 2-5 years of experience in pharmaceutical manufacturing or a related industry, with a strong understanding of pharmaceutical processes and GMP.

· Experience with commissioning/startup activities, cleanroom and contamination control practices (including smoke studies), process automation systems, validation, and cGMP/FDA regulatory requirements preferred.

Working Conditions / Physical Requirements:

· Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.

· Ability to work in cleanroom environments, including gowning requirements.