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Dan Wienczkowski, ACIR, CIR, CDR, CSSR, PRC posted a job: Process Validation Engineer in Bedford, OH - please send resumes to dan.wienczkowski@rightthinginc.com "Title: Process Validation Engineer Location: Bedford, OH Responsibilities: - Prepare, schedule and execute validation protocols. - Design testing strategy and methodology for the qualification and validation of products, cleaning processes, media fills, equipment, facilities/HVAC systems and utilities. - Prepare final report following execution. - Reviews Standard Operating Procedures (SOP's) and ensures the operational directions and parameters described in the SOP for equipment reflects validated conditions. - Support quality investigations resulting from process deviations and provides CAPA support. - Requires the flexibility and dedication to conform to a work schedule in which the start times are extremely variable. - Flexibility to work a non-standard work schedule. - Work around the Production Department to gain access to production equipment which needs to be validated. - Emergency response to breakdowns of Production equipment. - Performance of critical validations during shutdown or other holiday periods. Periodically working 2nd or 3rd shifts to meet aggressive timetables. Requirements: - Four year degree in an Engineering related discipline (i.e. Mechanical/Electrical Engineering or Engineering Technology), or a four year degree in a science related discipline (Chemistry, Biology or Microbiology - Minimum of two years validation experience in the pharmaceutical industry. - Requires understanding of cGMP regulations and industry standards regarding the validation of aseptic manufacturing processes. Please email your resume to - dan.wienczkowski@rightthinginc.com" |
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