Tim Mcnulty Email & Phone Number

Scranton, Pa, Us

Fishers, Indiana, Us

Consultant for Aseptic Processing for Fill/Finish Project

Paris, France, Fr

System Owner/Technical Subject Matter Expert (SME)• Engineering Technical Expert responsible for the filling line equipment (vial washer, depryogenation tunnel, filler, capper, tray loader) and barrier isolator (vaporized hydrogen peroxide) to support a new production building and product. Supported project schedule with on time receipt of equipment, project deliverables and budget from conceptual design through the detailed design and fabrication life cycle through CVQ execution with direct oversight of project personnel• Lead the equipment and process design team efforts for all systems with all equipment vendors ensuring all critical quality attributes and critical process parameters are incorporated• Responsible for all equipment documentation. Develop/review all P&ID’s, PFD’s, URS’, calculations and other design documents while applying site and global best practices guidelines and utilizing site/global and industry experts in these areas• Responsible for process manufacturing equipment from initial design and FAT activities through C&Q activities with training and handover to the Validation and Operations teams while working directly with the Quality organization. • Lead/Participated in Functional Component Criticality Assessments, System Level Impact Assessments, FAT documents, Critical Test Protocols (IQ/OQ/PQ), Non-Critical Test Protocols (IQ/OQ/PQ) etc. • Authored/Authorized Change Control Requests• Managed cross functional teams that included members from the following groups: Manufacturing, Maintenance, Manufacturing Technology (Validation), Engineering (Process Automation, Site Engineering), QA/QC, Safety, Microbiology, Process Improvement and Global representatives • Lead Engineer for Equipment Design in collaboration with Equipment vendors in Europe and led cross functional teams for equipment shakedown and FAT/SAT execution

Paris, France, Fr

System Owner/Technical SME for Building Retrofit Project • SME/Project Manager/Project Engineer for the Parts Washer project. Including building construction, installation, and CQ&V phases until handover to the Operations group including training of staff. • Lead engineer SME for Sterilizing Autoclaves, Decontamination Autoclave, Egg waste disposal systems, CIP skids, and Parts Washer systems • Led all FAT team executions overseas with punchlist closeout and all troubleshooting measures • Responsible for each system from initial design to final validation and handover were on schedule and within budget • Responsible for items including P&ID’s, PFD’s, design reviews, criticality assessments, punch list tracking, CQV documentation and execution, SOP/SWI’s, etc. Authored and/or reviewed these items. • Part of a project team that implemented new site C&Q plan successfully.

Paris, France, Fr

• Organized project timelines and schedules, delegated responsibilities, managed internal and external colleagues closed out qualification studies, data packs and resolved deviations that meet project goals and timelines.• System Owner/Technical Subject Matter Expert for Automated Visual Inspection machines of injectable preparations • System Owner/SME for validation of packaging equipment with direct oversight over maintenance technicians • Led team through IQ/OQ/PQ of multiple new visual inspection systems• Retuned the vision systems for vaccine strain to obtain maximum yield for worldwide distribution • Led CQV team to close out IQ/OQ studies for new facility for FDA Pre Approval Inspection

Senior Validation Engineer (consultant to other Pharma/Biotech companies) Minneapolis, MN• Authored procedures, protocols, criticality assessments etc. for various pieces of equipment including washers, tunnels, fillers, cappers and tray loaders. Also responsible for the oversight and execution of the CQV phases for these pieces of equipment. Also responsible for installation activities and equipment shakedown with Bosch on the vendor side and FAT’s for complete filling lines with customers.• Responsible for allocating available resources to meet each project timeline and the client’s goal• Primary contact between the client and all other contractors/consultants• Responsible for all deliverables, financial arrangements and budget tracking• Equipment integration activities, principally in sterile processing and vaccine manufacture• Completion of temperature mapping studies on bioreactors, autoclaves and incubators/refrigerators and validation of a process for the manufacturing of tablets with all the associated components• Led validation team performing Process Validation studies and reporting on solid dose filling lines for various presentations and equipment troubleshooting activities• Responsible for team of six validation engineers with respect to project timelines, deliverables, budget and future business development • Part of multifunctional Bosch team for equipment integration and shakedown activities and SAT testing and IFT• Performed PV activities on for a feasibility study for a new solid dose product. Performed statistical analysis on yield and performance.• CQV activities on Incubators, Refrigerators, Freezers, and other lab equipment• Various Testing includes but is not limited to: Air flow testing, particle monitoring, temperature mapping with lethality, loop checks, P&ID verification, fill accuracy, capping accuracy, line efficiency, etc.

Bs, Chemical Engineering

Minor, Chemistry