As a CBE Associate, Marcello offers highly specialized support within the biopharmaceutical sector and related fields. He excels in identifying solutions for design, compliance, validation, maintenance, and quality issues. Additionally, Marcello is adept at sourcing production equipment and conducting Factory Acceptance Testing (FAT) for clients.

Marcello is a highly accomplished Senior Pharmaceutical Consultant with extensive expertise in all aspects of sterile pharmaceutical manufacturing, packaging, facility redesign, equipment qualification/validation, and the management of maintenance departments and project management. With over 25 years of experience, he has a proven track record in developing, motivating, and shaping teams. His background includes significant experience in pharmaceutical quality systems, safety systems, and the recent design and layout of facilities, project management of builds, and sourcing production equipment for the cannabis industry, as well as environmental monitoring systems to ensure compliance with TGA and FDA requirements

Business Director, Engineer and owner of private Engineering Consulting Company. Consulting in all Pharmaceutical & Production sterile manufacturing - including maintenance and project management.Company ProfileUltimate Engineering Consulting Services P/L offers companies opportunity to tackle process improvements problems and projects without needing to employ full time or part time staff.Ultimate Engineering offers services and assistance in IQ,OQ,PQ validation as well as Project Management, primarily in Pharmaceutical and Food Industry. Ultimate Engineering has the ability to assist companies in creating maintenance structure set up, Trade advice as well as create PM's for equipment that suite the operating conditions for your production needs. We also offer long and short term Labour Hire for Companies - Engineering & Trade Maintenance servicing.Other services - ACAD services, production layout drawings as well as machine spare parts component drawings. We can assist in creating solutions for production/dispensing and packaging processes, including sterile production.We specialize in sourcing or manufacturing spare parts for European equipmentCurrent working on Projects and Process improvements for Aspen, AusCann, Cann Goup, THC Pharma, IDT Australia, Probiotec, Sandoz, Novartis and Zoetis (Pfizer) & BioCSL (Sequris)Major projects- redesign ISO 8 facility, Project management of facility scale up and installation & qualification of new - Tablet press & Blending equipment, Vacuum transfer.- Design new Liquid filling manufacturing TGA facility and project manage build and approval,- Full validation of new TGA facility,- Validation/Qualification of new high speed Tablet filling and packaging line - Project managing the start up of a sterile facility and FDA Audit readiness - Dealing with Novartis- Implementing Maintenance Management processes including Departments & Staff development. - Quality Audits - HSE advice and safety improvements

Managing the start up of a Sterile Facility and FDA Audit readiness - Consulting Under "Ultimate Engineering Consulting Services P/L"- Project Managing the start up of Sterile manufacturing facility which includes evaluating PM structures, IQ, OQ and PQ of dormant equipment. Recommissioning Utilities – Pure Steam, WFI, RO, PFW, as well as dispensing and packaging equipment. Auditing complete facility, procedures and PM system and advising on FDA Compliance improvements such as room grading re-classification and gowning requirement changes.- Pure Steam Quality Testing- Facility Redesign and project management of Upgrades- Sourcing of Manufacturing Equipment for future expansion- Implementing Maintenance Management processes including Departments & Staff development.- Implementation of safety processes such as Work Permits, JSA, ....

Key Member for Quality system building documentation system and assisting with relocation of facility to new Biocarna Facility in Clayton. Assisted in TGA readiness for start up of new facility. Machinery and line layout consulting.

Commissioning & Validation under Production Engineering Technology P/L.- Installation, Commissioning (SAT), Validation (IQ, OQ, PQ) & Documentation (Setting sheets through to Operating Procedures )of High Speed Panadol liquid filling and packing line. - Facility Consulting and Maintenance Back up.

Consulting Under "Ultimate Engineering Consulting Services P/L"Consulting on:- Quality Audits - Production process improvement projects - HSE advice and safety improvements- Process improvements, Packaging Machinery upgrades (Refurbishment)- Analysis of Production floor layout and modifications- Parts supply- Edwards Freeze dryer refurbishment

Qualifications / Experience• Strong Sterile pharmaceutical engineering, process and production maintenance experience • Operational Management experience• Extensive Project Management (Packaging Production Equipment/Facility upgrade)• Excellent knowledge of GMP and process validation.• Experience with computerized maintenance management system • Experience with managing trade staff & Engineering staff• Experience with dealing with unions & EBA agreements

Project Managed, Commissioned, Validated Processes & new production Lines as well as audited processes against TGA & FDA requirements

Project Manager for Automated NC equipment - Customer project Manager for Europe sales - design modification, commissioning & SAT

Commissioned new facility