<p>Description</p> <p>Job Purpose:</p> <p>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.</p> <p>This position includes hands-on involvement in cleanroom environments and requires strong technical, analytical, and documentation skills.</p> <p>Essential Duties and Responsibilities:</p> <ul> <li>Execute and support cGMP operations and project-based work, including commissioning activities, process studies, and quality system initiatives </li><li>Participate directly in facility and equipment commissioning activities, including field execution, documentation, and coordination with engineering and operations teams </li><li>Support and execute process and product development studies, including data collection, analysis, and documentation </li><li>Contribute to technology transfer and scale-up activities, supporting successful transition from development to manufacturing </li><li>Participate in cleanroom and controlled environment activities, including: </li><li>Supporting airflow visualization (smoke studies) </li><li>Assisting with cleanroom setup, readiness, and operational support </li><li>Execute and support CAPA-related projects, including root cause analysis, implementation of corrective and preventive actions, and effectiveness checks </li><li>Support deviations, investigations, and change controls through data gathering, documentation, and implementation of actions </li><li>Ensure all work is documented in accordance with cGMP requirements, maintaining accuracy, completeness, and data integrity </li><li>Collaborate cross-functionally with Manufacturing, Engineering, MS&T, and Quality teams to support facility startup, operational readiness, and continuous improvement initiatives </li><li>Participate in risk assessments and support mitigation activities related to processes, equipment, and cleanroom environments </li><li>Contribute to inspection readiness efforts, including documentation support and response to audit observations </li><li>Identify and support process and operational improvements across development and manufacturing activities </li></ul> <p>Requirements</p> <p>Education / Experience:</p> <ul> <li>Bachelor's degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or a related field. </li><li>2-5 years of experience in pharmaceutical manufacturing or a related industry, with a strong understanding of pharmaceutical processes and GMP. </li><li>Experience with commissioning/startup activities, cleanroom and contamination control practices (including smoke studies), process automation systems, validation, and cGMP/FDA regulatory requirements preferred. </li></ul> <p>Working Conditions / Physical Requirements:</p> <ul> <li>Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking. </li><li>Ability to work in cleanroom environments, including gowning requirements. </li></ul>