Job Details
Posted 29 May, 2026
Job Id: 625566
Process Lead
Job Description
Role: Process Lead (Senior level)
Employment Type: Full-Time or Contract
Location: Japan
Candidate Requirements:
- Must already be based in Japan
- English: Required
- Japanese: Not mandatory (nice to have)
Profile Overview
Senior Process Lead and Subject Matter Expert with extensive experience supporting greenfield pharmaceutical manufacturing facility projects, with particular expertise in Oral Solid Dosage (OSD) production environments.
Experienced in leading process design, equipment strategy, vendor oversight, and full project lifecycle support from early engineering phases through commissioning and start-up. Strong background in GMP compliance, process optimisation, and cross-functional collaboration within complex, large-scale capital projects.
Core Responsibilities
Process Design & Technical Advisory
- Acted as OSD Process SME across all project phases
- Defined and reviewed OSD process concepts including granulation, blending, compression, coating, and encapsulation
- Supported decision-making regarding process technology selection (batch vs continuous)
- Developed and reviewed Process Flow Diagrams (PFDs), material and mass balances, and detailed process descriptions
- Provided expert input on QbD frameworks, identification of CQAs and CPPs, and conducted process risk assessments
Equipment Strategy & Vendor Management
- Defined process equipment philosophy for OSD manufacturing
- Developed, reviewed, and challenged User Requirement Specifications (URS)
- Led technical evaluations of vendors, bid comparisons, and equipment selection processes
- Participated in FAT and SAT activities, providing technical oversight on behalf of the client
- Reviewed mechanical and process data sheets and vendor documentation
- Ensured compliance with specifications through vendor drawing review and inspection oversight
Greenfield Project Leadership
- Supported project delivery through basic design, detailed design, commissioning, qualification, and start-up phases
- Interfaced with engineering, automation, QA, validation, and EPCM partners
- Reviewed project deliverables to ensure GMP compliance and preservation of process intent
Engineering Oversight & Governance
- Monitored and reviewed technical deliverables from FEED/FEL and EPC contractors
- Verified alignment with engineering standards, project design bases, and process/utility requirements
- Reviewed engineering documents including PFDs, P&IDs, plot plans, hazardous area classifications, electrical diagrams, and building layouts
- Participated in HAZOPs, safety reviews, and model reviews
- Assessed contractor deviation requests and resolved specification conflicts
- Reviewed change claims and ensured technical validity
Utilities, Infrastructure & Environmental Compliance
- Reviewed utility balances and validated capacity against project requirements
- Assessed effluent material balances and treatment capacity
- Ensured compliance with environmental standards and regulatory requirements
- Supported optimisation of infrastructure, offsites, and utilities
Quality, Safety & Compliance
- Ensured adherence to GMP, quality standards, and project documentation requirements
- Reviewed engineering strategies, work processes, and standardisation approaches
- Supported safety, health, and environmental compliance
- Monitored development of operating philosophies including plant start-up and shutdown sequences
- Ensured engineering document handover aligned with EDMS requirements
Value Engineering & Optimisation
- Identified cost-saving and process optimisation opportunities
- Contributed to value engineering initiatives
- Supported development of integrated operating plans
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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