Giacomo Becheri
Sr Manager Validation
Bern,BE
Summary
Senior management professional with 15+ years of experience, bringing strategic leadership and operational excellence to drive organizational success. Proven leader in designing and implementing validation programs that ensure compliance and drive continuous improvement. Adept at developing high-performing teams and fostering collaboration to achieve operational excellence. Known for strong decision-making, effective communication, and building high-performing teams.
Overview
22
22
years of professional experience
Work History
Sr. Manager Validation, MSIT
Johnson & Johnson Innovative Medicine
04.2022 - Current
- Lead 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 deviations during external audits (in the last 3 years).
Manager C&Q, Technical Services, Janssen Vaccines
Janssen Pharmaceutical Companies of Johnson & Johnson
01.2020 - 03.2022
- 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.
C&Q Supervisor, Technical Services, Janssen Vaccines
Janssen Pharmaceutical Companies of Johnson & Johnson
01.2019 - 01.2020
- 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.
Team Lead Qualification, VPAD, Janssen Vaccines
Janssen Pharmaceutical Companies of Johnson & Johnson
10.2017 - 12.2018
- 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
Sr. Engineer Qualification and Validation, VPAD, Janssen Vaccines
Janssen Pharmaceutical Companies of Johnson & Johnson
10.2015 - 09.2017
- 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. Project Engineer
CTP TdP Spa (part of Akkodis)
10.2007 - 09.2015
- 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
CTP CHEM S.r.l.
01.2004 - 10.2007
- 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.
Education
Bachelor's degree - Chemical and Pharmaceutical Technology, Pharma Quality Control
University of Florence, Faculty of Pharmacy
09.2003
Skills
- Ability to Work Under Pressure
- Troubleshooting and problem resolution
- Team Player
- Leadership & Teamwork
- Process Validation
- Project Management
- Qualification and CSV
- Vaccines manufacturing
- Communication & Negotiation
- Cross-functional team coordination
- Adaptability
- Innovation
Accomplishments
- 2023: Achieved regulatory approval from Swissmedic, ANVISA, and FDA for the Lentivirus CAR-T process at Janssen Vaccines Bern, marking a significant milestone in product development and patients treatment
- 2022: Successfully executed process validation (PPQ) for the Lentivirus CAR-T project, leading to the completion of the Biologics License Application (BLA) submission at Janssen Vaccines Bern
- 2015-2022: Instrumental in supporting various Commissioning & Qualification (C&Q) projects that advanced the VPAD viral and bacterial platforms, facilitating the transition from Clinical Trial Material (CTM) to commercial phase production at Janssen Vaccines Bern.
- 2013-2015, Eli Lilly, RABS Cartridge Filling Line - Global Insulin Cartridge Program: Led the implementation of a new Restricted Access Barrier System (RABS) Cartridge Filling Line for Eli Lilly in Sesto Fiorentino, as part of the Global Insulin Cartridge Program. Authoring of specific tasks such as IQ/OQ/PQ and Media Fills. This project resulted in italian heath authority authorization.
- 2012, Kedrion SpA, Supply Chain Cold Shipment Validation Project: Served as Project Leader for the Supply Chain Cold Shipment Validation Project for Kedrion SpA, effectively coordinating logistical validation activities among teams in Germany, Austria, and Hungary.
- 2011-2012, Kedrion SpA, QA Validation Manager: Acted as QA Validation Manager at Kedrion SpA, overseeing a team of 10 people in periodic validation planning, and providing critical support for internal audits, AIFA and FDA inspections.
- 2011, Chiesi Farmaceutici Parma site, New Research Center Project: Successfully managed the validation process from commissioning to operational readiness for the new Research Center Project at Chiesi Farmaceutici in Parma, which received AIFA authorization.
- 2010/2011, Janssen Latina site (Italy), Technology Transfer Project: successfully performed validation activities for the Technology Transfer Project, ensuring compliance and efficacy of new laboratory equipment.
- 2009, Ely Lilly 6thOctober City site, New Egyptian Laboratory Project: Project Leader from commissioning phase to validation of laboratory equipment and plants. Egyptian Agency authorization granted.
- 2008/2009, Novartis V&D Rosia site, Automations Projects: Managed several automation projects at Novartis V&D Rosia, spearheading the validation of systems such as Track and Trace and manufacturing automation systems
LANGUAGES
Italian - Native speaker
English - Highly proficient
German - A2
Training
- Flawless Project Execution (FPX), Project Leader - 2018 — 2018, Johnson and Johnson
- Leading & Developing Successful Teams - 2018 — 2018, Management Forum
- First Line Leader Training - 2017 — 2017, Johnson and Johnson
- Lean Six Sigma, Yellow belt - 2014 — 2014, goleansixsigma.com
- Information Technology - 1997-10 — 1998-06, University of Florence
Hobbies and Interests
Running, cycling, reading, history, podcast, environment
Timeline
Sr. Manager Validation, MSIT
Johnson & Johnson Innovative Medicine
04.2022 - Current
Manager C&Q, Technical Services, Janssen Vaccines
Janssen Pharmaceutical Companies of Johnson & Johnson
01.2020 - 03.2022
C&Q Supervisor, Technical Services, Janssen Vaccines
Janssen Pharmaceutical Companies of Johnson & Johnson
01.2019 - 01.2020
Team Lead Qualification, VPAD, Janssen Vaccines
Janssen Pharmaceutical Companies of Johnson & Johnson
10.2017 - 12.2018
Sr. Engineer Qualification and Validation, VPAD, Janssen Vaccines
Janssen Pharmaceutical Companies of Johnson & Johnson
10.2015 - 09.2017
Sr. Project Engineer
CTP TdP Spa (part of Akkodis)
10.2007 - 09.2015
Sr. Analyst
CTP CHEM S.r.l.
01.2004 - 10.2007
Bachelor's degree - Chemical and Pharmaceutical Technology, Pharma Quality Control
University of Florence, Faculty of Pharmacy
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