Giacomo Becheri

• Lead, coach and mentor a dynamic validation department, overseeing daily operations and managing a team of 15 SMEs and engineers while aligning activities with the Johnson & Johnson CREDO and leadership imperatives.
• Design and implement comprehensive validation programs (PPQ, media fills/APS, Sterilization, Cleaning Validation, CPV) to support the development and manufacturing processes of Clinical Trial Materials (CTM) and commercial products, ensuring adherence to regulatory requirements.
• Leads the site validation approach in alignment with Global J&J policies & CMC teams to design & develop the validation strategy for the entire Bern project portfolio ensuring continuous improvement consistent with established and evolving regulatory and company requirements.
• Maintain current knowledge of regulatory trends and industry advancements, utilizing this insight to keep validation practices up to date.
• Establish annual goals and objectives for the validation team that align with site priorities and financial frameworks, driving high-performance outcomes.
• Oversee the creation and maintenance of Site Validation Master Plans, ensuring that all necessary documentation is current and accessible throughout the product lifecycle.
• Lead investigations related to deviations with impact on validation, facilitating cross-functional root cause analysis to address and resolve technical product/process issues.
• Ensure development and deployment of highly specialized skills appropriate to the validation team to meet the needs of the site's product portfolio and strategy.
• Act as a subject matter expert during health authority inspections and audits, providing critical support to internal teams. Achieved compliance with zero findings during external audits (in the last 3 years).

• Managed the Commissioning & Qualification (C&Q) team, providing leadership and ensuring compliance within a regulated environment to maximize the operational impact on pharmaceutical development.
• Accountable for the End-to-End C&Q and Computer Software Validation (CSV) business processes, reinforcing adherence to the site’s quality management system.
• Supervised daily activities and resource allocation for a team of up to 23 engineers, driving project completion and operational efficiency.
• Set and managed annual goals and objectives aligned with site priorities, ensuring integration with the financial framework.
• Authored and updated the Site Qualification Master Plans, ensuring that all qualification documentation meets regulatory standards throughout the asset lifecycle.
• Engaged actively in health authority inspections and audits, serving as a subject matter expert and providing essential support to team members.

• Defines the qualification strategy for production/ laboratory equipment, facilities, utilities and Computerized Systems (CSV)
• Maintain the qualification status of existing systems production / laboratory equipment, facilities, and utilities according to a predefined frequency and in accordance with current internal SOPs
• Ensure compliance of the qualification standards of the equipment/utilities through the continuous updating of procedures, according to international GMP standards and internal procedures.
• Actively participates in health authority inspections and all other audits for area of responsibility and acts as subject matter expert or provides support to peers.
• Writing and review of commissioning and qualification documents for equipment, utilities, facilities, and computerized systems. Definition of risk-based C&Q strategies. Deviation and CAPA management. Change Control Management.

• Responsible of the Qualification team in the Vaccines Development department (VPAD):
• Ensure all equipment, utilities and rooms are timely qualified according to company policies for all ongoing projects
• Provide technical leadership and accountability (Qualification SME)
• Participates regulatory inspections and internal audits
• Ownership for Change Controls, lead investigations, corrective and preventive actions
• Team leading (6 qualification engineers/external contractors)
• Coach, mentor, and develop staff, including onboarding of new employee and providing career development, planning and opportunities.
• Deputy of the R&D Operations support Manager in VPAD

• Responsible of qualification and validation activities for new biopharmaceutical processes in the Vaccines Development department to ensure that:
• Qualification and validation phases are performed according to global and local company policies and procedures as well as regulatory requirements.
• Qualification and Validation Master Plans are up to date and established for all projects.

• Sr. Engineer & Project Manager at customer sites. Commissioning, Qualification and Validation. Problem Solving. Project team Leader for Validation of utilities, cleanrooms and equipment used either in aseptic or non-sterile pharmaceutical productions. Cleaning and Process Validation. Computer System Validation. Validation of manufacturing automation systems and laboratory systems.
• Main customers: Novartis Vaccines (now GSK), Eli-Lilly, Kedrion, Janssen Cilag Latina, Chiesi Farmaceutici, Sanofi-Aventis, Bristol Meyers Squibb, Sigma-Tau.
• International experience in following the start-up of 2 new QC laboratories.

• Sr. Analyst and Project Leader for development and validation of analytical methods with respect of ICH guidelines. Cleaning Validation. Analysis for raw materials and batch release. HPLC, GC, UV-VIS skills. Laboratories FDA approved.