CQV Engineeer
PQE GroupCQV Engineer
Location: Japan – Hybrid / Client Sites
Employment Type: Permanent or Contract
About PQE
PQE is a global life sciences consulting company founded in Florence, Italy, in 1998. Today, PQE operates across 45 countries with more than 2,000 employees, providing specialized consulting services to the pharmaceutical, biotechnology, medical device, and other regulated life sciences industries.
Our services cover a broad range of areas, including Commissioning, Qualification & Validation (CQV), Computerized System Validation (CSV), Data Integrity, Regulatory Affairs, Inspection Readiness, and Quality Assurance.
At PQE Japan, you will have the opportunity to work on both local and international projects, collaborate with global teams, and develop your career in a highly regulated and technically challenging environment.
We value teamwork, integrity, innovation, and the professional development of our people.
Role Overview
PQE Japan is looking for experienced CQV Engineers with a background in the pharmaceutical, biotechnology, or medical device industries.
The successful candidate will be involved in the commissioning, qualification, and validation of facilities, utilities, manufacturing equipment, and systems, supporting clients throughout the project lifecycle.
Depending on experience, the role may also involve project planning, coordination, client interaction, and technical leadership of small project teams.
Key Responsibilities
* Prepare and review Commissioning, Qualification & Validation (CQV) documentation for pharmaceutical and/or medical device manufacturing facilities, utilities, and equipment.
* Develop and execute CQV protocols, including IQ/OQ/PQ, and prepare corresponding summary reports.
* Perform qualification activities for facilities, utilities, and manufacturing equipment at client sites.
* Support equipment and facility commissioning, including walkdowns, troubleshooting, punch-list management, and issue resolution.
* Develop and/or review technical documentation such as URS, FAT/SAT documentation, design review documentation, P&IDs, commissioning procedures, and qualification protocols.
* Support qualification of pharmaceutical utilities such as WFI, purified water/RO systems, HVAC, clean utilities, and building automation systems.
* Plan and coordinate CQV activities, monitor project progress, and ensure deliverables are completed accurately and within agreed timelines.
* Coordinate activities with clients, contractors, equipment vendors, and other project stakeholders.
* Provide technical guidance and support to junior team members and, depending on experience, coordinate small project teams.
* Support the preparation of project plans, schedules, procedures, and other project documentation.
* Ensure CQV activities are performed in accordance with applicable GxP and regulatory requirements.
* Contribute to continuous improvement of CQV methodologies, tools, and project execution practices.
Required Qualifications and Experience
* 5+ years of experience in CQV / equipment and facility qualification within the pharmaceutical industry.
* Bachelor’s degree or higher in a technical/scientific discipline such as Engineering, Chemistry, Biotechnology, Life Sciences, Information Technology, Physics, Mathematics, or a related field.
* Experience with commissioning, qualification, and/or validation of pharmaceutical facilities, utilities, manufacturing equipment, or systems.
* Practical experience with several of the following:
* Equipment commissioning and start-up
* Facility and equipment walkdowns
* Troubleshooting and issue resolution
* Pharmaceutical utilities, including WFI, RO/PW, HVAC, and clean utilities
* Building Automation Systems (BAS)
* Manufacturing processes and equipment
* FAT / SAT
* URS and design reviews
* P&IDs
* IQ / OQ / PQ protocol preparation and execution
* Solid knowledge of applicable GMP requirements, including cGMP, PIC/S GMP, and EU GMP.
* Business-level proficiency in both English and Japanese.
* Ability to work independently and take ownership of assigned responsibilities.
* Strong organizational skills, with the ability to manage multiple tasks and deliver high-quality work within defined timelines.
* Willingness and ability to work at client sites when required.
Preferred Qualifications
* Experience working as a technical SME in Computerized System Validation (CSV) and/or Data Integrity.
* Experience working on global or multinational projects.
* Knowledge of ISPE Baseline Guide 5 – Commissioning and Qualification, 2nd Edition.
* Experience coordinating or leading small CQV project teams.
* Strong analytical and problem-solving skills.
* High level of attention to detail and commitment to quality.
* Strong professional integrity and ethical standards.
* Experience working in a consulting environment or directly with pharmaceutical/biotechnology clients.
Working Conditions
Working Hours:
9:00–18:00 (1-hour break)
Work Location:
Japan – Hybrid
Remote work combined with travel to client sites depending on project requirements.
Employment Type:
Permanent or Contract
Holidays & Leave
* Saturdays, Sundays, and Japanese national holidays
* Annual paid leave
* Summer vacation
* Year-end/New Year holidays
* Bereavement and other special leave
Compensation
Expected Annual Salary: JPY 7,000,000–13,000,000
Compensation will be determined based on experience, technical expertise, and qualifications.
In principle, PQE aims to maintain the candidate’s current compensation, with flexibility to negotiate depending on experience and skills.
Benefits
* Full social insurance coverage:
* Health insurance
* Employees’ pension
* Employment insurance
* Workers’ accident compensation insurance
* Commuting allowance
* Career development opportunities within a global life sciences consulting organization
* Opportunities to work on international projects and collaborate with global teams
How to Apply
Please submit your English CV / Resume when applying directly for this position.