GxP Operations Support Specialist, Manufacturing Systems

Role: GxP Operations Support Specialist focused on supporting digital manufacturing systems, primarily MES, ensuring system implementation, maintenance, and continuous improvement in a GxP-regulated biopharma environment. Responsibilities: configure, test, and deploy system updates; support user acceptance testing; document requirements and test results; monitor operational issues; maintain documentation (SOPs, process maps); support end-user training and communications; analyze data for trends; develop understanding of manufacturing operations, electronic batch records, and GxP compliance; assist with system and process improvements. Requirements: Bachelor's degree or high school diploma with relevant biotech/pharma manufacturing experience; 1+ year in GMP/biopharma industry; strong attention to detail, problem-solving, communication, and ability to learn new technologies; familiarity with GMP, GxP, data integrity, and validation concepts. Preferred: experience with manufacturing systems, process documentation, and cross-functional collaboration. High-Value: focus on manufacturing digital systems, GxP compliance, GMP environment, and supporting continuous improvement initiatives. Work setup: on-site five days/week, with ad hoc flexibility.