• Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit. • Lead start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE). • Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements. • Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of manufacturing processes for compliance with quality and regulatory requirements. • Provide technical support for the product/process lifecycle and related activities. • Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed. • Provide support for improvement projects regarding processes and systems. • Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable. • Provide technical support for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration). • Analyze and recommend improved technology to increase quality and efficiency. • Provide technical analysis and support for new or improved process systems. • Facilitate and schedule meetings with subject matter experts across the organization. • Ensure compliance with cGMP, regulatory, and industry standards.