Oleg Klaverov
Project Engineer @Exentec Formerly Biopharm Engineered Systems
Signup · Get unlimited contacts
WORK HISTORY
Project Engineer @Exentec Formerly Biopharm Engineered Systems
Andover, MA, US
Size up and specify pumps, systems components, valves, analytical instruments, bioreactors for custom engineered process separation and fluid handling equipment for the biopharmaceutical industry.• Develop and customize P & ID for GMP processing equipment: UF/DF TFF, Depth Filtration, Chromatography, mixing, dilution and other custom-built both fixed and single use skids. • Ability to develop/use Engineering tools to identify issues between Instrumentation (I/O) and DCS/PLC software prior to startup /shakedown.• Provide technical support during fabrication; set up analytical instrumentation and control systems.• Perform P & ID and GA walk-downs to determine As-Built drawings represent the actual system and identify issues with instrumentation, and/or equipment fabrication.• Ability to conduct basic physical requirements of climbing ladders, work at elevated heights, ability to lift 40 lbs, and ability to use basic hand tools.
EDUCATION
Southwest State University (former Kursk State Technical University)
Bachelor of Science, Mechanical Engineering in heavy machine and automotive industries
Kursk Technical University
Bachelor of Science in Mechanical Engineering, Mechanical Engineer
University of Massachusetts at Lowell
Graduate Certificate in Foundations of Business, Business
University of Massachusetts
Master's Degree, Business Administration
SKILLS
ABOUT OLEG KLAVEROV
Proven team leader with demonstrated unusual dedication, self-motivated and strong ability to manage and execute changing objectives in a high-pressure, fast-paced business environmentAble to coordinate multiple projects to achieve desired business and technical objectives, meeting deadlines within budget. Passionate about quality and customer satisfaction.Technical Leader with extensive and diverse experience in biologics manufacturing technical services, validation, engineering design. cGMP manufacturing, clinical formulation development, and drug product aseptic fill-finish aspects of technology transfer.Collaborative problem solver who identifies root cause by translating complex processes into clear and understandable steps to achieve resolution.Developed and provided technical trainings for manufacturing operations staff to build effective work force.The established requisites resulted in 21CFR Part 11 compliant records. The collected data were effectively used with various complex analyses.Played integral role in identifying and harmonizing best practices across multiple manufacturing facilities.Led temperature mapping and steam-in-place (SIP) validation efforts of various process equipment, and discrepancy resolution during qualification process.• Manufacturer of sterile fill/finish product• Technology Transfer• Process Development • Process Optimization• Aseptic Processing• Manufacturing Compliance• Regulatory Inspections (FDA, EMA )• Deviations, Investigations and Quality Systems• cGMP and ICH guidelines• Manufacturing Operations• Batch Records and SOPs• Lyophilization • Data Analysis • Statistical Process Control (SPC)• Equipment Design• Equipment and Utility Qualification • Tangential Flow Filtration or UF/DF• Temperature mapping (SIP)• Cleaning validation• Process validationLeadership• Team Building• Cross-functional negotiation skills • Project management
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.