Michael Bubnick Email & Phone Number

Lawrence Township, Nj, Us

ASO-GLS Sr Manager with primary responsibilities supporting S6A Biologics Clinical Processing Facility and S7 Analytical Strategy & Operations - Analytical Regulated Testing GMP laboratory group. Manage permanent and contracted staff of up to 13 resources responsible for all GMP laboratory instrumentation installation, qualification and PM/PV/Calibration activities as well as maintenance of CMMS. Responsible for all qualification lifecycle changes including upgrades, relocations, retirements, requalifications, disaster recovery. Responsible for data integrity assessments and configuration of computerized systems.Primary reviewer/approver for all qualification deliverables including but not limited to validation plans, protocols, UAT's, URS's, configuration specifications, RTM's, reports, change controls, CAPAs, Deviations.Responsible for hiring/staffing decisions and support generating RFP's for calendar year scope of work. Serves as primary CQV SME in audits.

Lawrence Township, Nj, Us

ECQ-Delivery Manger with primary responsibilities supporting S6A Biologics Clinical Processing Facility and Analytical Strategy & Operations - Analytical Regulated Testing GMP laboratory group in S7, in addition to numerous non-GMP laboratory groups in S7. Manage contracted staff of up to 16 resources responsible for all equipment/instrument/facility/utility installation and qualification activities with scopes consisting of GMP Computerized Systems, GMP Non-computerized systems and non-GMP equipment. GMP Computerized System Qualification including configuration of systems, part 11 testing, performing data integrity assessments for systems such as Delta V Bioreactor Process Control System, Spectrophotometers, FTIR, Titrators. GMP Non-Computerized Systems consisting of but not limited to GC, HPLC/UPLC, ph meters, dissolution systems, tube sealers, tube welders, cryogenic freezers, centrifuges. Responsible for all qualification lifecycle aspects including work categories of upgrades, relocations, retirements, requalifications, disaster recovery. Primary ECQ reviewer/approver for all qualification deliverables including but not limited to validation plans, protocols, UAT's, URS's, configuration specifications, RTM's, reports, change controls, CAPAs, Deviations.Responsible for hiring/staffing decisions and support generating RFP's for calendar year scope of work. Serves as primary CQV SME in audits.

Raritan, Nj, Us

• Provide validation support including reviewing and approving protocols, reports and deviations for cold chain shipping validations, centrifuges, cell washers, incubators, refrigerators, freezers, walk-in cold boxes, tanks, laboratory analyzers, parts washers.• Generate and execute protocols and generate reports for filling lines, refrigerators, freezers, incubators, cold rooms.• Provide worldwide regulatory agency audit back room support in addition to serving as a scribe. • Address CAPA observations.• Create validation process maps for manufacturing processes.• Revise, consolidate and improve validation guidance within global and site specific procedures.

Downingtown, Pennsylvania, Us

• Generated and executed HVAC IOQ and Facility IOQ for 3500 sqft of new class C and D clean rooms• Critical utilities lead assigned to generate and execute IOQ's and PQ's for critical utilities including new WFI and Clean Steam systems

Downingtown, Pennsylvania, Us

• Generated and executed HVAC PQ, Refrigerator and Freezer IOPQ's, Process Validation and Isensix (Building Monitoring System) Qualification documents.• Developed protocol final reports and deviations.• Assigned to manage phase 2 build out of current facility which consists of planning and coordination of a new area for relocated equipment, new equipment and systems. Includes maintaining equipment database, performing heat load calculations and revising equipment layout maps.

Downingtown, Pennsylvania, Us

K-15 Biologics Expansion Project (new construction portion $170 million project, 140,000 net sqft) Merck, Kenilworth, NJ• Managed commissioning project team regularly consisting of 4 members, but up to 8 team members at peak. Consisted of document generation and field execution of Installation and Operational Commissioning of over 100 systems. • Responsible for developing project infrastructure which included generating entire project system list of over 100 systems. Populated components and associated drawings for each system. • Reviewed over 200 project P&ID's and drawings to determine commissioning system boundaries. Highlighted and defined system boundaries on all drawings for each system.• Assisted with generation of the project schedule linking predecessors and successors to each system in order to determine commissioning sequence. Assisted with assigning schedule durations for field execution tasks.• Generated Installation and Operational Commissioning documents for utilities and process systems. • Performed drawing walk downs and signed as-builts, verifying construction in accordance with design documents.K-15 Discovery Pre-Clinical Sciences Renovation Project• Responsible for developing project infrastructure which included generating entire project system list, with over 90 systems. Populated components and associated drawings for each system.• Reviewed over 100 project drawings to determine commissioning system boundaries. Highlighted and defined system boundaries on all drawings for each system.• Managed and led project team by delegating responsibilities to the entire team of up to 3 team members at peak. Coordinated and planned workloads for all team members and tracked progress. • Performed drawing walk downs and signed as-builts, verifying construction in accordance with design documents.

Downingtown, Pennsylvania, Us

Merck, West Point, PA - Bldg 70• IOQ for various reach-in stability chambers, Bio Safety Cabinets, walk-in cold rooms and a water system. Merck, Rahway, NJ - Bldg 53• Cold room temperature mapping PQ.Dendreon, Union City, GA - Immunotherapy Mfg Start-Up Fac (160,000 sqft)• Coordinated and led a 10 member temperature mapping execution team for the validation of 66 Manufacturing Incubators. Dendreon, Morris Plains, NJ - Immunotherapy Mfg Fac• Temperature mapping activities using Lives wireless data logger equipment for Incubators, Refrigerators, Freezers and Cold Rooms. • Determined faulty calibrations as the root cause for 30 failing incubators, then scheduled and led an execution team for the validation of 92 Incubators.Schering-Plough, Summit, NJ - Bldg S6 ($220 million, 200,000 sqft)• Generated and maintained a project master spare parts list and procured all process equipment and utilities spare parts on a budget of $660,000. • Managed the MEL change control process.• Assigned and maintained project procedure training of all Schering-Plough personnel, contractors and vendors.Roche Molecular Systems, Branchburg, NJ• Autoclave Performance Re-qualification protocol execution.Dendreon, Morris Plains, NJ - Immunotherapy Mfg Fac• Managed, planned, and performed all project temperature mapping activities using Kaye equipment and Validator 2000 software. • IOQs and PQs for various equipment including liquid nitrogen controlled rate freezers, refrigerators, incubators, biological safety cabinets, scales, air samplers, and centrifuges.Schering-Plough, Kenilworth, NJ - Bldg K-11• IOQs for walk-in and reach-in Stability Chambers, Refrigerators and Freezers. Schering-Plough, Union, NJ - Bldg U-22 USP Water System Repl Proj• Developed QMP, PEP and SOP’s for the U-22 Temp USP Water Gen Sys.• Com, IOQ, PQ, Eng Study and Summary Reports for the U-22 Temp USP Water Gen Sys.• Com document and IOQ for the U-22 Permanent USP Water Gen Sys.

Large Scale Erbitux Pilot Plant, Building BB50 ($260 million project, 250,000 sqft)• Performed P&ID walk downs and protocol execution for utility systems, including air compressors, compressed air coolers, air receivers and dryers.• Signed utility system As-Built drawings.• Developed Operational Qualification protocols for multiple bioreactors and media prep tanks.Merck & Co., Rahway, NJ - High Pressure Hydrogenation Pilot Plant Expansion ($30 million project, 36,000 sqft)• Developed and executed over 50 Installation Qualification and Mechanical Completion (IC) protocols including glass washers, fume hoods, DI water, solvent delivery, HVAC and vacuum systems.• Performed P&ID walk downs, verifying construction in accordance with design documents.• Developed and maintained databases, and progressed and expedited completion for protocol exceptions and project punch lists.Merck & Co, Rahway, NJ - Small Scale Organics Pilot Plant - Potent Compound Handling Upgrade ($25 million project)• Developed over 20 Installation Qualification and Mechanical Completion (IC) protocols including glove boxes, portable sampling carts, line filter carts, HEPA filter carts and process transfer lines.• GMP review of design documents and their conformance with the P&IDs (Instrument Index, Line List, X-Item List)Merck & Co., Rahway, NJ - Multiple-Scale Organics Pilot Plant ($500 million project, 200,000 net sqft)• Performed P&ID walk downs for over 80 process and utility systems including reactors, centrifuges, dryers, laminar flow booths, hazardous waste, heat transfer fluid distribution, utility and HVAC systems.• Executed IQ and IC protocols including PM verification, vendor documentation review and pipe line test/flush verification.• Developed and expedited closeout of protocol exception reports.• Field verified CMMS data and installed Maximo identification tags for over 2000 instruments and equipment.