Sergi Malets Email & Phone Number

United States

Greater Minneapolis-St. Paul Area

• Managed Capital Projects and Facility Expansion initiatives.• Developed technical drawings in AutoCAD and Visio for GMP facilities.• Provided support during the installation, maintenance, repair, and calibration of capital GMP equipment.• Developed preventive maintenance program for facilities and equipment.• Managed Environmental Monitoring System (Mesa Labs Viewpoint).• Developed and executed facility qualification protocols.• Finished capacity projects on time and within budget.• Prepared estimates and budgets for capital projects.• Defined facility design specifications for the installation of capital equipment.• Initiated and reviewed Scope of Work, Request for Proposal, Field Change Orders and Purchase Request documentation.• Initiated and managed change controls and CAPAs related to manufacturing processes within GMP facilities.

United States

• Developed, reviewed, and executed commissioning, qualification (IQ, OQ, PQ), and validation (PV) documents for facilities, R&D processes, equipment, and computerized systems.• Assisted in troubleshooting process issues, conducted process characterization, and contributed to root cause investigations.• Resolved deviations and non-conformances encountered during the execution of qualification and validation activities.• Validated software applications related to Quality Control.• Analyzed data from Environmental Monitoring System to ensure compliance with FDA regulations.• Performed impact assessments on new processes and equipment.• Provided technical support in the development of test plans, protocols, reports, SOPs.• Prepared traceability matrices for computerized systems (Oracle, GLIMS, Mesa ViewPoint)• Assisted with the development of user requirement specifications for capital GMP equipment.• Initiated, managed, and ensured proper implementation of change control procedures.• Developed Performance Based Training forms for operation and maintenance of manufacturing equipment.• Investigated equipment failures, identified causes, and initiated methods to resolve them.• Scheduled validation testing with different departments and managers.• Provided continuous process improvement to facilitate operational efficiency.• Maintained and calibrated testing equipment.

Greater Minneapolis-St. Paul Area

• Developed and performed commissioning, qualification (IQ, OQ, PQ), and validation documents related to facilities, processes, and equipment.• Investigated and resolved discrepancies encountered during qualification and validation procedures.• Initiated change controls, CAPAs, and conducted investigations on equipment failures and out of tolerances.• Supported in diagnosing process-related issues, conducted process characterization, and performed root cause analyses.• Developed and reviewed equipment Standard Operating Procedures (SOPs).• Orchestrated planned calibration services.• Managed scheduled preventative maintenance services and associated tasks.• Collaborated with service providers to ensure prompt execution of calibration, qualification, and maintenance services.• Maintained the equipment database system, ensuring accurate and updated records.

Greater Minneapolis-St. Paul Area

• Managed, executed, and documented commissioning, qualification, and validation procedures for pharmaceutical packaging equipment sourced from various Bosch locations globally.• Organized and carried out internal testing protocols for new equipment at Bosch facilities.• Authored and updated commissioning and qualification templates tailored for Bosch equipment.• Created and maintained documentation related to validation activities such as traceability matrices and risk analysis documents.• Provided technical support in the installation, configuration, and qualification of Bosch equipment.• Investigated equipment failures, identified causes, and initiated methods to resolve such issues.• Scheduled validation testing with different departments and managers.• Supervised and led a team consisting of Bosch employees and customer representatives during testing procedures.

United States

• Conducted timely routine maintenance, troubleshooting, and repairs on dialysis equipment and water treatment systems following manufacturer's guidelines.• Managed the procurement and upkeep of a service parts inventory through approved channels.• Undertook water/dialysate sample collection, processing, and contributed to assessing and reporting quality results based on relevant policies and procedures.• Assisted in the installation of medical equipment and devices.• Conducted safety inspections on all clinic-owned medical equipment and devices.• Monitored performance levels of existing biomedical systems to ensure optimal functioning.• Provided training sessions to clinical staff on the proper use of newly installed medical instruments.• Analyzed data collected from tests performed on various pieces of biomedicine technology.

Ramsey, Mn, Usa

• Completed preventive maintenance, calibration, and repairs on optical processing equipment.• Supported maintenance and engineering teams.• Performed root cause analysis of technical issues.• Identified areas of process improvement through root cause analysis.

Applied Management, Business Administration And Management, General

Associate Of Science - As, Biomedical Technology/Technician