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.

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.

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.

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.

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.

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.

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.

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.
• 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.

• 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.

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.

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.

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