For Equipment Validation services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in Science (P harma, Chemistry or Engineering ) & five ( 5 ) years of exposure in the Pharmaceutical industry. Three (3) years in solid oral dosage forms. Bilingual (English & Spanish) Experience in: Technologies and processing equipment for oral dosage forms, including packaging technologies. Validation Life Cycle: IQ/OQ/PQ for equipment/utilities. Process improvement. The Personality Part: We're looking for a confident people-person, who's a great leader (people listen to you!) and effective decision-maker. Add to this a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, and you might just be what we're looking for! AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Conducts process/packaging equipment installation/operational/performance qualification studies to test their functionality for the manufacture of parenteral products. Conducts critical sterilization/Dehydrogenation/bio-decontamination equipment (tanks, autoclaves & SIP, tunnel, isolator), utilities and facilities qualification studies (Critical utilities/systems includes Purified Water, HVAC, compressed gases) to ensure that a system functions as to routinely produce results that meet predetermined specifications. Conducts temperature/relative humidity mapping qualification studies (cold boxes, freezers, and incubators) to ensure that a system functions as to routinely produce results that meet predetermined specifications. Prepares operational qualification assessments to support that validated critical operating parameters are within qualified parameters for specific parenteral products. Identify and evaluate equipment enhancements to support intended qualified operational ranges. Hands on experience in the use/troubleshooting of validation equipment such as KAYE Validator AVS, thermocouples and temperature/relative humidity data loggers. Supports the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications. Supports process capability and statistical analysis related to equipment performance within parenteral manufacturing process. Serves as Subject Matter Expert for qualifications during regulatory audits (internal and external). Supports the periodic review of equipment/system qualifications studies. Assists and performs as the liaison person with the Information Technology Department in the implementation and qualification of upgraded equipment control systems and automation initiatives. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece? Powered by JazzHR
