4466 - Principal Engineer - Validation LOCATION: Rochester, NY This is a Retained Executive Search, our client is a Major health products organization with the oldest, best known and most respected healthcare brands in the world. We are searching for a Principal Engineer ? Validation If you are interest please forward your resume and I will respond back ASAP. POSITION DETAILS Salary Range: $84K - 105K w/15% bonus US Citizen or Permanent Resident [Green Card Holder] only Best Industry- Healthcare Department : Quality Assurance , Research & Development 4 Year Degree 5-10 years exp Up to 10% Travel Relocation allowance of one (1) month?s salary. Individual will be responsible for leading validation activities to the Process Development Department, a R&D aseptic processing facility, in support of FDA compliance. Activities include: preparation and execution of validation strategies, FAT, IQ, OQ, PQ & PV validation protocols, and reports for equipment and processes. You will be responsible for the design, preparing specifications, design review, installation and startup of new equipment, design changes and modifications to existing equipment and utilities that support the equipment for aseptic processing in Process Development. Job Duties: Prepare IQ, OQ, PQ & PV validation protocols and final reports for Process Development. Provide guidance for troubleshooting during validation activities as warranted, and review and analyze data generated during a validation. Coordinate validation and revalidation activities on a routine basis per Process Development schedule for maintaining equipment & processes in a validated state. Assist in the selection of appropriate vendors for Process Development equipment purchase and modifications. Prepare plans, timing estimate, scope of work and bid documents as necessary for equipment purchase/modifications and utilities installation for the Process Development organization with internal maintenance facilities and/or external contractors. Work with selected vendors and affected parties to schedule work for minimum business impact. Provide cleaning and sterilization validation strategies for Process Development. Maintain an annual validation strategy and a validation archive for Process Development. Act as an engineering technical resource for equipment trouble-shooting and problem-solving as necessary to maintain schedules in the Process Development department. CANDIDATE MUST HAVE: Bachelor?s degree, preferably in Engineering or Microbiology Minimum of 8 years experience in an engineering or equivalent position in a pharmaceutical or medical device manufacturing or research environment Experience with Purified Water Systems, Clean Steam Systems, Autoclave, Cleanrooms, HVAC Systems and aseptic processing are highly desirable Knowledge of cGMPs for medical devices and pharmaceutical Good interpersonal, organizational, communication and execution skills