Quality Engineer

Job description

A brief overview The Quality Engineer (QE) / Validation fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations What you will do: - Develop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports - Perform, coordinate, execute and analyze cleaning recovery studies. - Lead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables. - Provide qualification / validation guidance and strategy during project planning and development phases. - Train, coach and mentor team members. - Write validation protocols and final reports, test methods, standard operating...