Commissioning & Qualification professional with excellent hands-on experiences in Equipment Qualification Fermenter /Bioreactors/Wave Bioreactor/Chromatography/Process Vessels), Equipment Validation (Fermenter /Bioreactors/Chromatography/Process Vessels), Automation Engineering in Bio process Manufacturing Processing & cGMP requirement. Working knowledge in FDA cGMP and 21 CFR part 11 regulations. GAMP software validation guideline, and ISO's regulations. Experience of validation documents (Commissioning/validation plans/Test protocol/IQOQ/FAT/SAT and technical Summary Reports). Hands-on experience on GDP documentation execution. Energetic Field Service Engineer with 7 years background performing repairs, installations and troubleshooting. Committed to providing optimum service support through phone and personal visits. Proficient in investigating and troubleshooting common problems and providing efficient, courteous and professional repair services. Quality-focused Technical Field Service Engineer offering 7 years of field service experience. Detail-oriented and proactive with diligent and focused approach to managing projects, reviewing work and coordinating call responses. Maintains strong internal, supplier and customer relationships for maximum effectiveness. Knowledgeable Field Service Supervisor with top strengths in planning, problem-solving and communication. Skilled in maintaining high customer satisfaction, controlling inventory and providing technical support. Skilled at training and mentoring field service personnel to troubleshoot and correct problems, consistently meeting or exceeding expectations. Well-versed in safety practices and gear, documentation requirements and compliance standards for
Biopharmaceutical industry.