US – Engineering Skilled Trade Expert 6

Description Develop and validate autoclave sterilization cycles per current regulatory requirements (EN285, etc.) Develop and maintain sterilization and equipment re-qualification program using risk-based approach Create and execute IQOQPQ protocolsreports for equipment (Manufacturing and Lab equipment) and utilities (CDA, CO2, HVAC, Water Systems) Perform risk assessmentsFMEAs for equipment Act as technical lead for a cross-functional projects Interact with cross-functional groups to coordinate activities and ensure effective communication Support site expansion project to ensure validation activities are completed per site requirements Work with equipment vendors to define requirements and understand functional specifications Ability to effectively solve technical problems and form solutionsplans to mitigate issues independently Basic Qualifications BS in Engineering or related scientific field required MS preferred 7 years of experience with BS 4 years of experience with MS Minimum of 4 years of experience with Equipment and Sterilization validation including autoclave sterilization IQOQPQ experience for labmanufacturing equipment and utilities Working knowledge of current regulatory guidelines and standards Expertise with Quality Risk Management concepts Technical writing skills to create plansprotocolsreportsSOPs for validation projects Preferred Qualifications Experience in Biologics manufacturing Experience supporting validation projects associated with new facilitiesexpansion Understanding of principles and concepts of Lean Six Sigma to continuously improve qualification program Experis is an Equal Opportunity Employer (EOEAA)