MICHAEL KUFO
Overview
3
3
years of professional experience
Work History
C&Q Engineer
Eli Lilly
Indianapolis
02.2024 - Current
- Directed commissioning and qualification processes for new Lily facility.
- pharmaceutical equipment.
- New equipment included large scale bioreactors, HVAC, water supply, compressed air and nitrogen lines
- Developed user requirements, created commissioning/qualification protocols (URS, FAT, SAT, DQ, IQ, OQ), utilizing Kneat software.
- Conducted P&ID walk-downs, equipment verification, and ensured compliance with calibration and certification standards
- Performed commissioning and qualification activities by optimizing cGMP procedures through comprehensive OV testing using Delta-V.
- Performed pressure, leak, functional, transfer, and batch testing.
- Conducted HVAC commissioning and qualification for sterile and non-sterile facilities.
- Managed protocol deviations, including root cause analysis and corrective actions
CQV Engineer
Biogen
Solothurn
01.2023 - 01.2024
- Prepared and operated Kaye Validator for Bioreactor SIP PQ, performing SIP runs on various tank sizes and autoclaves, while collecting data with Osisoft Pi software
- Also Co-ordinated all temperature mapping and validation on equipment such as fridges, freezers, autoclaves, incubators and stability cabinets
- Calibrated and verified thermocouples for qualification using a Heat bath with IRTD to maintain reliability and performance
- Maintained SOPs / WIs associated with Qualification & Validation studies
- Managed installation and removal of thermocouples and BIs for large-scale bioreactors, transfer lines, and skids
- Analyzed sterilization data, created qualification, graph and summary reports for equipment cycles upon completion of SIP run
- Developed SIP final reports and deviations
Validation Engineer
Biogen
Solothurn
01.2022 - 12.2022
- Project: Swissmedic Remediation Project, a key initiative focused on resolving compliance issues and improving regulatory processes within pharmaceutical manufacturing
- Hands on experience in developing and documenting Validation Master Plan, Validation Summary Report, Traceability Matrix and Standard Operating Procedures SOPs
- Prepared Design Qualification (DQ) reports and Spray Coverage Test Review reports for Biogen's Solothurn site and Swissmedic observations
- Worked with cross functional teams, system owners and stakeholders to review and approve documentation
- Managed and executed Kneat documents, including CQV (IQ, OQ, PQ) protocols and reports, while maintaining document tracking metrics
- Extensive knowledge of FDA regulations 21CFR Part 11 Electronic Records, Electronic signatures and Audit Trails
Education
B.Sc. (Hons) - Physics with Bioengineering
Technological University Dublin (TUD)
Dublin, IrelandHighlights Of Skills And Qualifications
- Successfully managed multiple projects within timelines and budgets, ensuring adherence to cGMP, Good Automated Manufacturing Practice (GAMP), and regulatory requirements
- Authored and executed multiple protocols (IQ/OQ/PQ) for critical manufacturing equipment and utilities, ensuring operational readiness.
- Knowledge of 21 CFR Part 11 compliance in a GMP/GLP regulated industry, Data Integrity, GDP and adherence to ALCOA principles.
- Proficient in Microsoft Office Suite, Delta-V software, Kneat documentation software, and Osisoft Pi software. Strong aptitude for learning new technologies and optimizing processes.
References
Professional references available on request.
Timeline
C&Q Engineer
Eli Lilly
02.2024 - Current
CQV Engineer
Biogen
01.2023 - 01.2024
Validation Engineer
Biogen
01.2022 - 12.2022
B.Sc. (Hons) - Physics with Bioengineering
Technological University Dublin (TUD)