Lead Process Engineer

Provide technical support for operations, troubleshooting, repair and maintenance of existing and new manufacturing processes and equipment used in radiopharmaceutical and aseptic manufacturing operations. Develop new manufacturing capabilities and optimize existing manufacturing processes. Serve as a Subject Matter Expert and Responsible Engineer for various unit operations, especially vial filling line equipment. Lead, perform, or oversee all aspects of assigned projects, including specification, design, selection, installation, commissioning, and qualification. Essential FunctionsEnsure equipment and run readiness of new isolated vial filling line and associated cleaning, sterilization, formulation, inspection, labeling, and support areas.Lead and participate in investigations to drive technically and scientifically sound corrective and preventative actions.Lead and execute continuous improvement projects to provide optimal radiopharmaceutical and aseptic manufacturing processes. Use defined, data-driven methods to identify, select, and prioritize these projects.Develop and specify new equipment and process capabilities working closely with aligned groups in Manufacturing, Quality, Facilities and Manufacturing Automation.Prepare project cost estimates and funding requests; work with other groups to obtain required approvals.Manage, coordinate, and oversee development of user requirements for new projects/equipment. Coordinate and lead team review of designs/deliverables and document spect or direct the inspection of work to ensure conformance to design drawings, specifications, schedules, and safety regulations.Manage equipment and process validation, either acting as the validation engineer or working with the Validation department.Provide support in the development, review and maintenance of operational SOPs and predictive/preventive maintenance job plans.As a Subject Matter Expert (SME) on the manufacturing equipment, provide technical training to other departments.Actively promote safety rules and awareness.Actively demonstrate the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.Typical Minimum Skills and Experience and EducationBachelor''s Degree in Mechanical, Electrical, Chemical Engineering or related discipline. Six (6) or more years of experience in manufacturing of parenteral pharmaceutical products, or an FDA regulated automated manufacturing facility. Prior vial filling line experience.Expert knowledge of MS Office suite, particularly Excel. Other RequirementsThis individual should be a self-starter with the ability to work well both independently and in a team environment.Effective problem-solving skills.Strong project management skills.Excellent organizational and time management skills.Excellent oral & written communication skills. Ability to develop technical presentation materials and present.Demonstrated ability to write and review technical documents.

Created: 2025-11-15