Associate Engineer, Biopharmaceutical Manufacturing Resume Miriam Joshi Associate Engineer, Biopharmaceutical Manufacturing (608) 555-1842 miriam.joshi@example.com linkedin.com/example/miriamjoshi Madison, WI 53711 STRENGTHS Field Troubleshooting When skid pressure drift returned, reviewed trends and records together, then coordinated corrective work that restored stable operation. Asset Data Quality Maximo updates gave planners clearer job plans, spare parts, safety details, and preventive maintenance information for critical assets. Reliability Thinking A review of vibration, temperature, and work history helped maintenance address deterioration during planned windows, not production campaigns. Investigation Leadership For abnormal equipment conditions, gathered operator and technician evidence, documented conclusions, and gave Quality partners a clear action path. Cross Functional Delivery Design reviews and commissioning work brought engineering, operations, maintenance, and validation together around practical handoff decisions. SKILLS Mammalian Cell Culture Protein Purification Clean Utilities Process Troubleshooting Reliability Engineering Maximo Preventive Maintenance Condition Based Maintenance Predictive Maintenance Data Analytics Deviation Investigations Commissioning Qualification CIP SIP LANGUAGES English Native 40 Hindi Proficient 30 MY CAREER 3.9 Years Associate Engineer, Biopharmaceutical Manufacturing at Northstar Bioprocess Solutions (2.2 Years) Engineering Associate, Biopharmaceutical Manufacturing at Lakeview BioManufacturing (1.7 Years) SUMMARY Associate Engineer with four years of progressive experience supporting regulated biopharmaceutical manufacturing , process equipment, clean utilities, maintenance, and reliability programs. Bachelor’s trained chemical engineer with hands on experience across Mammalian Cell Culture , Protein Purification, CIP, SIP, Production Services, and non GMP utility systems. Diagnoses field equipment and control issues through trend review, instrument history, maintenance records, and operator observations, then coordinates practical corrective action. Experienced with Maximo asset records, job plans, spare parts, safety information, preventive maintenance, condition based maintenance , deviation investigations, commissioning, and qualification support. Collaborates with Manufacturing, Quality Assurance, Validation, Process Engineering , Maintenance, and Utilities teams while communicating risks, findings, and proposed resolutions clearly. Supports startup, shutdown, off hours operations, and regulated documentation with steady attention to safety, quality, schedule, and reliability. EXPERIENCE Associate Engineer, Biopharmaceutical Manufacturing Northstar Bioprocess Solutions July 2024 - Present Madison, Wisconsin Supports commercial biologics operations through daily engineering coverage for cell culture, purification, CIP, SIP, and clean utility systems. Owns field troubleshooting, asset data quality, reliability reviews, deviation work, startup support, and qualification documentation while coordinating technical decisions with senior engineers and cross functional partners. Supported cell culture, purification, CIP , SIP, and clean utility equipment during commercial manufacturing operations . Diagnosed skid pressure instability using control trends, instrument history, and maintenance records, stabilizing performance before campaign start. Updated Maximo hierarchies, job plans, spare parts , safety details, and preventive maintenance tasks for process assets. Reviewed vibration, temperature, and work order history, adding condition based review points for rotating equipment. Supported design reviews, construction walkdowns, startup, commissioning, and qualification for modified clean utility distribution systems. Led scoped deviation investigations , documenting evidence, conclusions, risks, and proposed actions for Quality Assurance and Validation. Engineering Associate, Biopharmaceutical Manufacturing Lakeview BioManufacturing October 2022 - June 2024 Milwaukee, Wisconsin Supported process and reliability engineering across upstream and downstream manufacturing, Production Services, non GMP Utilities, and controlled bioprocess systems. Worked with technicians, automation partners, Manufacturing, Quality Assurance, Validation, Process Engineering, and Utilities teams on troubleshooting, maintenance planning, commissioning, qualification, and shutdown readiness. Supported upstream and downstream equipment across Production Services , non GMP Utilities , and controlled bioprocess systems. Investigated equipment alarms with technicians and automation partners, isolating instrumentation and mechanical causes through trend review. Prepared maintenance data summaries and recommendations, helping lead engineers prioritize shutdown work against production schedules. Revised preventive maintenance tasks and spare parts information after equipment history reviews, clarifying planner requirements. Contributed to commissioning and qualification through walkdowns, punch list follow up, turnover records, and protocol support. Coordinated issue resolution across Manufacturing, Quality Assurance, Validation, Utilities, and Process Engineering partners. PROJECTS Clean Utility Distribution Modification 2024 Supported a modified clean utility distribution system from design review through walkdowns, startup, commissioning, and qualification documentation. Field coordination kept technical issues visible and supported controlled handoff into operations. Rotating Equipment Reliability Review 2023 Reviewed vibration, temperature, and work order history for rotating assets, then helped add condition based review points. Maintenance teams gained clearer timing for intervention during planned operating windows. LEADERSHIP & AWARDS Recognized by engineering and maintenance peers for clear field troubleshooting and practical issue resolution during manufacturing support. Selected to lead scoped deviation investigations involving abnormal equipment conditions, evidence review, technical conclusions, and partner communication. EDUCATION Bachelor's Degree in Chemical Engineering University of Wisconsin Madison GPA: 0 2022 Madison, Wisconsin Coursework: Process design, thermodynamics, fluid mechanics, biochemical engineering CERTIFICATIONS Engineer in Training (EIT), Wisconsin 2022 Good Manufacturing Practice Training 2022 TECHNICAL SKILLS Bioprocess Systems: Mammalian Cell Culture, Protein Purification, Production Services Utility Systems: Clean Utilities, CIP, SIP, non GMP Utilities Asset Management: Maximo, equipment hierarchies, asset records Maintenance Planning: Job plans, preventive maintenance, spare parts Reliability Methods: Condition based maintenance, predictive maintenance, work order history Data Analysis: Control trends, instrument history, vibration data Project Delivery: Design reviews, construction walkdowns, startup Commissioning Support: Commissioning, turnover documentation, punch lists Qualification Support: Qualification protocols, qualification documentation, validated conditions Quality Systems: Deviation investigations, abnormal conditions, technical conclusions Manufacturing Operations: Commercial manufacturing, clinical manufacturing, shutdown execution Technical Collaboration: Manufacturing, Quality Assurance, Validation SKILLS Mammalian Cell Culture Protein Purification Clean Utilities Process Troubleshooting Reliability Engineering Maximo Preventive Maintenance Condition Based Maintenance Predictive Maintenance Data Analytics Deviation Investigations Commissioning Qualification CIP SIP PROFESSIONAL AFFILIATIONS Cross Functional Biopharmaceutical Engineering Collaboration with Manufacturing, Quality Assurance, Validation, Maintenance, and Utilities teams. Wisconsin Engineering Community participation through Engineer in Training development and regulated manufacturing practice. LANGUAGES English (Native) Hindi (Proficient) ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. REFERENCES AVAILABLE ON REQUEST
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