QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units. Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Qualifications: Bachelor's degree in Microbiology, Life Sciences, Engineering or related area Five (5) years of previous experience Experience in CDOCs, KNEAT, MS Office Experience in Aseptic Process Simulation (Media Fills), Airflow Visualization Studies (Smoke Studies), Environmental Characterization/Qualification Experience in Parenteral Manufacturing, Isolators Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body. Able to troubleshoot systemic validation issues. Technical expertise areas of validation engineering. Working knowledge of financial analysis tools. Advanced validation knowledge (equipment qualification, cleaning, sterilization). Administrative Shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR
