Position Summary: Responsible for supporting manufacturing operations through technical investigations, process monitoring, documentation review, and continuous improvement initiatives within a regulated biopharmaceutical environment. The role requires collaboration across Manufacturing, Process Development, Quality, and other cross-functional teams to ensure compliance, product quality, and operational excellence. Key Responsibilities: * Support manufacturing operations and bio-processing unit operations activities. * Conduct and support investigations, deviations, and root cause analyses. * Monitor manufacturing processes and identify opportunities for continuous improvement. * Collaborate with cross-functional teams including Manufacturing, Process Development, Quality, and Engineering. * Prepare, review, and maintain technical documentation in compliance with Good Documentation Practices (GDP). * Analyze process data and trends using available systems and monitoring tools. * Support Lean Manufacturing and operational excellence initiatives. * Prepare technical reports,



presentations, and documentation for management review. * Ensure compliance with applicable regulations, procedures, and quality standards. Required Qualifications: * Bachelor’s Degree in Engineering, Biotechnology, Life Sciences, Microbiology, Chemistry, or a related scientific discipline. * Experience in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. * Strong written and verbal communication skills in English and Spanish. * Proficiency in technical writing and presentation development. * Ability to work effectively in a team-based environment. * Excellent interpersonal and collaboration skills. * Ability to work independently with minimal supervision. * Availability to work under high workload conditions and extended hours when required. Preferred Qualifications: * Experience in bio-processing unit operations. * Knowledge of Root Cause Analysis (RCA) meth

📌 Sr. Investigator Specialist (Cataluña)
🏢 Mentor Technical Group
📍 Cataluña