Representative
Representative Profile
CQV JAPAN, Representative Director
Suguru Matsuzawa松澤 卓
24 years in pharmaceutical engineering & CQV
CQV / GMP / Qualification / Validation
Profile
Bridging the site and quality
After graduating in mechanical engineering from Kyushu University in 2002, Suguru began his career in pharmaceutical facility engineering. His experience spans the equipment lifecycle, from introducing and constructing manufacturing equipment through URS, risk assessment, DQ, FAT, IQ, OQ, PQ, technology transfer and GMP compliance.
He has worked on solid dosage equipment, packaging lines, secondary packaging for parenterals, and utilities such as HVAC, compressed air and purified water, connecting the technical, quality, process and stakeholder sides of each project. Drawing on this hands-on experience, he now focuses on supporting CQV work and developing the next generation of engineers.
- Three perspectives
- C&Q experience from the side that builds facilities (a general contractor), the side that operates them (pharmaceutical manufacturers) and the side that supports qualification (a CQV engineering consultancy).
- Full lifecycle
- From URS and risk assessment through DQ, FAT, SAT, IQ, OQ, PQ, process validation and technology transfer.
- Working in English
- At multinational pharmaceutical companies, led meetings with overseas colleagues and handled technical communication with contract manufacturing organizations (CMOs).
Career
2026–
CQV JAPANRepresentative Director
Provides technical support for CQV of pharmaceutical facilities and develops CQV engineers.
2025–2026
CQV engineering consultancyPrincipal CQV Engineer
Led the development of C&Q procedures for client projects. Responsible for design reviews, commissioning, execution of FAT, IQ, OQ and PQ, vendor coordination, effort estimation and quotations, and mentoring junior engineers.
2022–2025
Multinational biopharmaceutical companySenior Engineer (technical support for contract manufacturers)
Responsible for syringe, vial and autoinjector products: technology transfer of overseas products for the Japanese market, qualification of a syringe secondary packaging line and vial lines, technical coordination with CMOs, and leading meetings with overseas colleagues.
2014–2022
Multinational pharmaceutical companyEngineering Manager / Packaging Manager
Managed maintenance of facilities including HVAC, compressed air and purified water, GMP and HSE management, and equipment projects including qualification. Later, in packaging, responsible for qualification of blister packaging lines and GMP compliance.
2011–2014
Multinational pharmaceutical companyTechnologist (technical department)
Responsible for technology transfer of tablet and granule products, API changes and project management.
2002–2011
Japanese general contractorEngineer (engineering division)
Managed construction projects for pharmaceutical production lines and equipment, and qualification from URS through DQ, FAT, SAT, IQ and OQ.
Graduated from Kyushu University, Faculty of Engineering (mechanical), 2002
The above describes our representative’s personal experience in previous roles and does not represent projects delivered by CQV JAPAN. Company and project names are withheld for confidentiality.
Areas of expertise
CQV / C&Q
GMP & quality systems
Projects
Equipment: Solid dosage
Equipment: Packaging & parenteral-related
Equipment: Utilities & facilities
Outreach
Suguru shares practical GMP and CQV insights for pharmaceutical facilities on YouTube, X and LinkedIn (primarily in Japanese).
Contact
Planning a CQV project in Japan?
Let's talk.
From early planning to supporting part of an ongoing project. Tell us about your situation, in English or Japanese.