Robert Sciascia Email & Phone Number

Basel, Switzerland, Ch

- Represent site QA Validation SPOC (Single Point of Contact) for Facility Equipment and systems, Computerized Systems, Laboratory systems and participate on SOP authoring/review and implementation to site. Approves Validation strategy and plans for the site. - Act as SME (Subject Matter Experts) to develop validation and qualification procedures, train and guide site personnel in validation area including guidance on audit preparations or leading investigations whenever required- Support establishment, review and approve maintenance plans and calibration strategy, and execution in collaboration with site Engineering function.- Review of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters- Review/approve investigation of operations in manufacturing/laboratory or other related operations. Oversee resolution of quality events, monitor that recurrent events are properly escalated and resolved. Ensure root cause is determined, evaluate impact on product quality, disposition and corrective actions- Review and approve changes related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC studies.- Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures. Act as Responsible Person for the final disposition of products.- Ensures supplier qualification activities are performed, including audits execution and Quality Agreements preparations.- Contribute to generation of Annual Product Reviews.- Primary SME for GMP regulatory inspections, specifically for qualification and validation matters- Ensure the coaching and training of the quality team and other associates within the Production and QC in qualification and validation field

Paris, France, Fr

*Manage, plan, oversee construction, write, and execute commissioning, validation, IQ, OQ, PQ, IOPQ, qualification documents and summary reports for autoclaves, parts washers, temperature containers, mixers, control boxes, emergency generators, freezers, and powder bag lifts to support manufacture of Moderna Covid 19 vaccine.*Perform design reviews, equipment specification reviews, and submittal reviews.*Write summary reports to capture commissioning and IOPQ test results for utilities and manufacturing equipment to support contract manufacturing of Moderna Covid19 vaccine.*Perform viable/non-viable particle testing, smoke studies, temperature mapping, and rom qualification.*Write SOPs and User Requirement Specifications for AHUs, clean steam, and manufacturing equipment to support contract manufacturing of Covid19 vaccine for Moderna.*Review utility system risk assessments to verify proper assignment of direct, indirect, or no impact designations to each system based on User Requirement Specifications.*Perform investigations and write Deviation Reports to close out non-compliant issues encountered during validation execution.*Update redlined drawings using AutoCAD program and rout to for approval signatures. *Write Trace Matrix documents to verify full conformance of validation documents to user requirement specifications.*Build turnover packages for commissioned and validated utilities and manufacturing equipment.*Upload qualification documents into Geode system for review and approval workflows.

Rahway, New Jersey, Us

Lead team of commissioning and qualification professionals. Review Drawings, Tun Over Binder packages, URS, Test Matrix, IQ, and IOQ documents, in addition to summary reports for qualification of CGMP utilities and production / lab equipment. Walk down systems against drawings, write URS, Test Matrix, IQ and IOQ documents. Meet with Merck management to strategize plan for qualification of GMP utilities and production / lab equipment.

Switzerland 🇨🇭 , Ch

Utilities• Write, and execute IOPQ documents for AHUs, Purified Water, Compressed Dry Air systems to support new building expansion at the Roche Branchburg New Jersey site.• Write summary reports to capture results of executed commissioning and validation protocols.• Write User Requirement Specifications for AHUs, Purified Water, and Clean Compressed Air systems.• Review utility system risk assessments to verify proper assignment of direct, indirect, or no impact designations to each system based on User Requirement Specifications.• Walk down newly constructed HVAC and utility systems to verify that installed equipment matches with make, model, and performance specifications information listed on contractor submittals.• Walk down and red-line As Built drawings to verify that drawing details match with field installation of HVAC and utilities.• Manage third party contractors performing environmental testing on Compressed Dry Air System.• Provide turnover requirements piping contractor(s) for stainless steel piping, including material certs, weld logs, isometric weld diagrams, bore scope videos of internal welds, and welder certifications.Lab Equipment• Plan, write, and execute IOPQ qualification for Chromatography Equipment, Packaging Equipment, and Temperature Controlled Units supporting Roche laboratories.• Write User Requirement Specifications for temperature controlled freezers and refrigeration units supporting Roche laboratories.• Build binder packages for temperature controlled freezers and refrigeration units supporting Roche laboratories.• Generate document numbers, and close out fully executed protocols in TrackWise system.• Enter Change Control information into the client TrackWise system.• Close out calibration of equipment instruments in Blue Mountain (BRAM) system.

Basel, Baselstadt, Ch

• C&Q Project Lead for CO2 system expansion project.• Managed, planned, and executed qualification of a new CO2 system at Novartis Morris Plains NJ site.• Wrote the URS for the new and existing CO2 systems.• Wrote the Design Qualification for new CO2 system.• Wrote the Commissioning Protocol and Commissioning Summary Report for the new CO2 System.• Wrote IOPQ Protocol and IOPQ Summary Report for new CO2 system.• Wrote the Trace Matrix for new CO2 System.• Performed CAD updates to CO2 System drawings using AutoCAD.• Wrote the Work Plan and to connect the new CO2 tank piping and integrate into the existing CO2 system • Managed piping contractors and provided a list of required turnover requirements for stainless steel piping, including material certs, weld logs, isometric weld diagrams, bore scope videos of internal welds, and welder certifications.• Held pre construction safety meetings with piping contractors to review Novartis safety requirements.• Wrote the Impact Assessment for the CO2 System expansion project.• Wrote the Implementation Plan for the CO2 System expansion project.

Paris, France, Fr

*Commissioning and Qualification of Room Components, Utilities, and Manufacturing Equipment.*Write / manage Change Controls for new facility Inspection and Packaging Rooms, and related utilities.* Perform gap assessments, compile findings spread sheets, and execute corrective action.* Write and execute commissioning protocols to challenge installation and operation of critical utilities and manufacturing equipment.* Write Commissioning Summary Reports to summarize results of commissioning protocol execution* Write Engineering Reports to summarize product study laboratory test results. * Walk down utilities / manufacturing equipment, and redline design drawings to match as found field conditions* Assist with CAPAs related to unresolved issues encountered during execution of commissioning protocols* Build electronic ETOP turnover packages with supporting documentation for commissioning and qualification of critical utilities and manufacturing equipment* Work with cross functional teams on a daily basis to communicate progress, and request technical information where required.

Toronto, Ontario, Ca

* Write and execute IOQ protocols for laboratory freezer temperature mapping studies at Janssen Pharmaceuticals.* Perform Kaye Validator calibrations before and after temperature mapping studies. * Write deviations for non conformance issues encountered during temperature maping studies. * Write IOQ and Validation Summary Reports for laboratory freezer temperature mapping studies.

Paris, France, Fr

*Performed all aspects of qualification required to successfully execute and close out qualification of HVAC and associated BAS Systems serving classified production areas.*Perform deviation investigations; write root cause analysis and preventive / corrective actions.•Write / implement Change Controls for clean utilities, including HVAC and associated BAS systems.*Write SOPs for operation of newly installed equipment and clean utilities.*Write and execute IOQ test procedures to challenge critical HVAC and BAS attributes*Write URS, DR / DQ, and FCCA documents for clean utility systems.*Write NCTP (Non Critical Test Protocols) for clean utility systems.*Write Final Reports for completed CTP, NCTP and IOQ protocols for clean, and non-critical utilities.*Execute Mechanical Completion Verification forms to document proper installation of clean, and non-critical utility systems and components*Assemble and organize data packs for completed protocols

•Write / execute Installation qualification for instruments and equipment associated with HVAC, Clean Utilities, and manufacturing equipment•Write / execute Operational qualification for instruments and equipment associated with HVAC, Clean Utilities, and manufacturing equipment•Write / execute Performance qualification for instruments and equipment associated with HVAC, Clean Utilities, and manufacturing equipment•Write preventative maintenance SOP for instruments and associated equipment.•Write User Requirement Specifications for instruments and associated equipment.•Write / implement Change Controls for manufacturing equipment.•Write Commissioning Plans, Validation Plans, Gap Assessments, Final Reports.•Write / execute Integrated Functional Testing for control of multiple integrated systems. •Write Project Qualification Plans (PQPs) to outline a strategy for conducting system/equipment qualification•Write sampling plans to provide details on inspection methods and ensure AQL limits for each defect classification are met.•Perform Quality Review of documents to verify conformance to good documentation practices, client specifications, and client quality requirements.

Blue Bell, Pa, Us

Provided full range of Commissioning and Validation services for Sanofi and Bristol Myers Squibb

Blue Bell, Pa, Us

Support activities at Merck West Point facility related to install of new HVAC and Clean Utilities.Write Commissioning and Mechanical Completion Checklists, IOQ documents for HVAC, Siemens BAS System, and clean utilities. Perform field walk downs - drawing verification, loop checks. Execute PFC, FC checklists, and IOQ protocols.

Paris, France, Fr

Support new and retrofitted HVAC and clean utility installations for client. Write URS, FRS, DDS, Commissioning Plan, Validation Plan, Commissioning / Mechanical Completion Checklists, IOQ, PQ docs. Review design against client specifications. Perform FAT / SAT, perform field walk downs - drawing verification, loop checks. Program HVAC points in BMS system - vaidate all new points. Execute PFC, FC checklists, and IOQ, and PQ protocols.

Paris, France, Fr

• Review system and equipment specifications against submittals and design drawings to verify compliance with client requirements.• Establish and define system and equipment boundaries.• Wrote User requirement Specifications based on owner needs and equipment usage.• Wrote Detailed Functional Design Specifications. • Develop and write commissioning plans.• Perform Factory Acceptance Tests, installation, and Site Acceptance Testing of critical equipment.• Perform, separate Factory Acceptance Test for HVAC Controller Software package, including controller object names, controller object functions, and inter-active screen graphic functions. • Verify certification of Terminal HEPA Filters, laboratory hoods and other critical equipment.• Write “System Level Impact Assessments” to define criticality level for each system based on anticipated “product contact” or “process impact”.• Write “Functional Component Criticality Assessment” to define criticality level for each component based on anticipated “product contact” or “process impact”.• Write, and execute Critical Test Protocols for critical system equipment, instruments and components. • Write, and execute Installation Qualification Protocol to verify proper installation / mechanical completeness of system and component against client specifications. • Write, and execute Operational Qualification Protocols to challenge operation of equipment and components against client requirements.• Write, and execute Performance Qualification Protocols to challenge functionality of systems against client requirements.• Write Deviation Reports, including investigations, root cause, and corrective actions.• Write Change Controls. • Write summary reports for all executed protocols.• Write and multiple qualification documents in Sanofi eDoc System.• Build Data packs and Engineering Turn over Packages for each piece of qualified equipment.• Write equipment specs per client User Requirements as required.

Seal Beach , Ca, Us

Perform reverse engineering to dissect computer chips to identify manufacturing and/or design defects using a variety of equipment including scanning electron microscopes, focused ion beams, mechanical polishers, x-ray machines, and chemical techniques.Write reports to outline findings and corrective actions.

Associate Degree Earned, Electronic Technology

Education record