Erp, Functional Testing, iso standards, maintenance strategy, EHS standards, Bms, Plc, ASRS, Instrument Calibration, automation system installation, Troubleshooting, GMP regulatory requirements, Mes, operation verification

Pharmaceutical biotechnology, cGMP processing, Electronic batch records, Manufacturing Monoclonal Antibodies, Technical knowledge of equipment design, Cell Culture and Upstream Processing, Distributed control systems, Cell and Gene Therapy, Project lifecycle, equipment selection, Downstream Processing, Aseptic best practices, FMEA Risk Assessments, Single-use technology, Process Design, Emerson DeltaV

Excel, Biotechnology process development, Statistical Data Analysis tools, Process Support

Cleaning Impact Assessments, On-site Quality Management Processes, Quality Management, Gmp

IQ OQ PQ, qsr, Iso 13485, FDA 21 CFR Part 820, Engineering principles and practices

Equipment reliability, GMP compliance, Risk Assessment, MS Project software, PSSR, Hazop, Project cost control, Cost Estimation, Data management practices, Testing and validation procedures

Preventive Maintenance, risk assessments, Change Control, Fmea, Hazop, reliability engineering, Predictive Maintenance, Maximo, Cmms, Root Cause Analysis, CAPA development

iso standards, Microsoft Office Excel, GMP training

Oee, Lean, Spc, basic PLC, Doe

Quality Management Systems, IEC 62941, Iso 9001, 8D problem solving methodology, Fmea, Spc, Msa