Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations. Participate in project teams to develop comprehensive specifications (hardware and/or software) for equipment with minimal functionality such as fixtures, PLC's, and simple Visual Basic applications. Provide project estimates with assistance from senior/principle engineers. Develop comprehensive software validations and/or equipment installation qualification protocols per the specification. Execute software validation and/or qualification protocols & record results. Provide basic information on software validations and equipment installation qualifications. Support Equipment Installation & Qualification and retrofits Ensure Work carried out as part of Primo is as per procedures. Candidates must possess at least Bachelor's Degree in Engineering (Mechanical, Manufacturing, or related field). Required at least minimum 3-5 years of experience in equipment engineering. Proven track record in product transfers, equipment qualification, and equipment setup and improvement. Experience in working within a matrix organization and cross-site collaboration. Strong project management and technical documentation skills. Proficient in equipment qualification protocol/report writing (ESQ). Skilled in root cause analysis and process&equipment improvement methodologies. Wiling to travel for oversea assignment/training.
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