
Cssbb Alexander Bichutsky Pmp
An accomplished seasoned engineering professional executive with over 20 years of managerial and technical progressive experience working for... | Cedar Knolls, New Jersey, United States
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Cssbb Alexander Bichutsky Pmp’s Emails bi****@co****.com
Cssbb Alexander Bichutsky Pmp’s Phone Numbers No phone number available.
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Cssbb Alexander Bichutsky Pmp’s Location Cedar Knolls, New Jersey, United States
Cssbb Alexander Bichutsky Pmp’s Expertise An accomplished seasoned engineering professional executive with over 20 years of managerial and technical progressive experience working for Fortune 100 companies across multiple industries. Leverage engineering and business expertise of systems development lifecycle, methodologies, standards, tools and techniques to provide leadership in designing and implementation of technological solutions and best practices in highly regulated industries. • Working knowledge of Industry Regulations, Guidelines and Compliance requirements: 21 CFR11, 21 CFR210-211 (cGMPs), 21 CFR820, ISO13485, ISO 14644, ICH Q8 Q9 Q10, ISPE/GAMP • Methodology and guidelines for Risk-Based approach to compliant GMP Computerized Systems Life Cycle Validation: URS/FS/DS/DQ/FRA/ IQ/OQ/PQ • Project, Change Control and Quality Management in regulated environment: methodology, tools and practices (TrackWise, Agile, QbD, QRM, FMEA/FMECA) • Automotive Production Systems, Pharmaceutical, Bio-Medical Devices and Consumer products manufacturing and packaging: operation, process, equipment and technology. • Engineering and project management experience in the high-volume manufacturing of mass customized product operations providing 24/7 technical support and continuous improvement initiatives through utilization of Six Sigma and Lean methodologies • Comprehensive project and hands-on experience in all levels of the Factory Floor Automation Environment including development, enhancements and remediation of existing systems: PLC, HMI, SCADA, Vision inspection systems and robotic automation solutions. Industry 4.0: Digital Transformation and IIoT, ISA-S88 and ISA-S95, manufacturing cloud computing and virtualization, networking. • Data Governance, Quality and Life Cycle Management in TechOps (compliance to ACLOA+, DI assurance, DG framework, auditing). • Product Serialization / Track & Trace for Pharmaceutical Packaging operations and Supply Chain: Drug Supply Chain Security Act (DSCSA) milestones and requirements, GS1 standards and implementation guidelines, technology solutions and implementation, operations, QA/ Compliance
Cssbb Alexander Bichutsky Pmp’s Current Industry Novartis
Cssbb
Alexander Bichutsky Pmp’s Prior Industry
Wallas And Tiernan
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Ford Motor
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Marcal Paper Mills
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Novartis
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Lts Lohmann Therapy Systems
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Integra Lifesciences
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Comar
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Work Experience

Novartis
Automation & OT Engineering Manager
Wed Nov 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Novartis
Information Technology Project Manager, Automation/OT & CSV
Sat Oct 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Nov 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Comar
Manager, Automation & Controls
Wed Jul 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Oct 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Integra Lifesciences
Sr. Engineer, Automation & Controls
Mon Aug 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jul 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Lts Lohmann Therapy Systems
Senior Electric Automation Engineer
Sat Aug 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Aug 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Novartis
Manager Process Automation / IT Support
Thu Sep 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Marcal Paper Mills
Electrical & Instrumentation Maintenance Manager
Tue Jun 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Ford Motor
Maintenance Engineering Superintendent
Thu Jun 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jun 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)
Ford Motor
Computer Integrated Manufacturing, Technical lead
Sun Mar 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jun 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)
Ford Motor
Automation Engineer
Sun Sep 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Mar 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time)
Ford Motor
Technical, Construction and Maintenance Supervisor
Thu Jun 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Sep 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time)
Wallas And Tiernan
Machine Maintenance Engineer
Mon Apr 01 1991 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jun 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time)