Sr. Engineer

Company DescriptionQRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!Job DescriptionThe Senior Engineer is focuses on process support for Drug Substance operations, with a strong emphasis on process monitoring, data analysis, and continuous improvement. The ideal candidate will bring technical expertise, cross-functional collaboration skills, and a passion for driving operational excellence in a regulated environment.Key Responsibilities Provide technical support for Drug Substance manufacturing processes, including troubleshooting and deviation investigations. Lead process monitoring activities: collect, analyze, and interpret process data to identify trends and opportunities for optimization. Collaborate with cross-functional teams (Manufacturing, Quality, Engineering) to ensure robust and compliant operations. Author and review technical documentation including electronic batch records, process validation protocols, and change controls. Utilize systems such as SAP, TrackWise, and document management platforms to support operations and compliance. Support technology transfers, scale-up activities, and implementation of process improvements. QualificationsEducation & Experience: Doctorate (Ph.D.) in Engineering or related field Master’s degree in Engineering + minimum 2 years of relevant experience Bachelor’s degree in Engineering + minimum 4 years of relevant experienceRequired Skills: Strong understanding of Drug Substance manufacturing processes and GMP regulations. Experience with process monitoring, data collection, and statistical analysis. Proficiency in SAP, TrackWise, electronic batch records, and document management systems. Excellent communication and problem-solving skills. Ability to work independently and in cross-functional teams. Additional InformationAll your information will be kept confidential according to EEO guidelines.