Quality Engineer

Quality Engineer

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.

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.