C&Q/Validation Engineer-Pharmaceutical manufacturing

Job Description

About Our Client

Our client is an established global life sciences consulting organisation headquartered in Europe, supporting pharmaceutical manufacturers across commissioning, qualification, validation, quality engineering and regulatory compliance.

We are seeking an experienced C&Q / Validation Engineer to support existing plant operations and a major CAPEX expansion project at a pharmaceutical manufacturing site in Narita.

This role combines hands-on site execution, validation documentation and cross-functional coordination. The successful candidate will proactively drive activities, resolve technical challenges and keep qualification and validation work progressing against project milestones.

Key Responsibilities

• Drive project planning and site execution: Coordinate schedules, track progress, resolve issues, assess risks and escalate potential delays or quality concerns early.
• Author, execute and review validation documentation: Prepare Validation Pilot Plans (VPP), User Requirement Specifications (URS), System Risk Assessments (SRA), Design Qualification (DQ), FAT/SAT documentation, IQ/OQ/PQ protocols and summary reports.
• Conduct technical and impact assessments: Review P&IDs, functional specifications, Cause & Effect diagrams, alarm lists and I/O lists to determine GMP and qualification impacts.
• Maintain the validated state: Support periodic reviews, change impact assessments, requalification assessments, deviation and exception handling, retesting proposals and technical input for CAPA.
• Support multiple equipment domains: Deliver commissioning and qualification activities across process equipment, utilities, HVAC, automation and laboratory equipment.
• Coordinate stakeholders and vendors: Work closely with engineering, manufacturing, quality and project teams, preparing GMP documentation in Japanese and communicating with overseas equipment suppliers in English.
  
  

Qualifications

Required Experience and Qualifications

• Typically 810+ years of relevant experience, including hands-on commissioning and qualification of pharmaceutical manufacturing equipment.
• At least 3 years of experience in equipment implementation projects within a regulated pharmaceutical environment.
• Proven ability to independently author, execute and review lifecycle qualification and validation documentation, including VPP, URS, SRA, DQ, FAT/SAT, IQ/OQ/PQ and summary reports.
• Ability to interpret P&IDs, equipment specifications and automation documentation.
• Solid understanding of GMP, Good Documentation Practice and Data Integrity requirements.
• Strong site coordination, stakeholder communication and practical problem-solving skills.
• Ability to independently evaluate quality, safety and schedule risks, develop mitigation options and present clear recommendations to client decision-makers.
• Fluent Japanese, including technical discussions and GMP documentation.
• Professional working proficiency in English for international vendor coordination and technical communication.
  
  

Preferred Experience

• Experience with Kneat Gx, Veeva Vault, TrackWise, SAP, Microsoft Power BI or Microsoft 365 Copilot.
• Cleaning Validation experience, including master planning and swab/rinse sampling.
• Sterilization Validation experience, including heat distribution and penetration studies and F0, biological indicator and chemical indicator verification.
• Familiarity with automation and Computer Software Validation (CSV).
• Experience managing contractors and equipment vendors.
  
  

Working Arrangement

• Five-day working week, typically four days on-site and one day remote, subject to business needs.
• Standard working hours: 8:30 a.m.5:15 p.m.
• Full-time on-site attendance, holiday work or work outside standard hours may be required during plant shutdowns or peak execution periods.
  
  

Why Is This a Great Opportunity

• Contribute to a major pharmaceutical plant expansion while supporting ongoing manufacturing operations.
• Take ownership of hands-on execution across a broad range of equipment and systems.
• Work with Japanese site teams and international equipment suppliers.
• Apply your technical expertise in a role with meaningful responsibility for quality, delivery and project outcomes.
  
  

Salary Type : Annual Salary

Salary Min : ¥ 10000000

Salary Max : ¥ 12000000

Currency Type : JPY