· Develop and execute validationnand equipment qualification protocols to meet regulatory requirements.
· Assess and develop any amendmentsnto the qualifications to deliver fully validated equipment into productionnwithin agreed timelines.
· Provide guidance to sites withnrespect to validation/process deviations and change control as it pertains tonsystems and test equipment in production.
· Support the validation program and proceduralnchanges that enhance safety, compliance, and overall operational efficiency.
· Support the site’s adherence to the ValidationnMaster Plan.
· Continuously evaluate and identify opportunitiesnfor improvement in existing validation programs and procedures.
· Participate in device risk management activitiesnincluding DFMEA and PFMEA.
· Provide direct technical support on productionnissues (e.g. part & assembled product quality dispositions, interimncontainment actions, root cause analysis, resolution planning, validation,n& implementation) under NCMR or CAPA.
· Able to develop all documentation required for a 21nCFR Part 11 validated project, including Validation Plans and Summaries.
· Approve validated computer system related changenrequests.
· Assist in planning, implementing, and documentingnuser acceptance testing.
This position requires a minimum of Bachelor’sndegree in Mechanical Engineering, or closely related field.