Lead Process Engineer (SME)

Yamagata
09-04-2026
Job Type
Contract
Emp Type
Full Time
Functional Expertise
Any
Salary Type
Hourly
Salary
Negotiable

Job Description

OSD Process Lead / Senior OSD Process SME

 

Contract Details: 

Greenfield Pharma Project

Yamagata, Japan (Onsite, 5 days/week)
12 month renewable contract 

The Role 

We are seeking an experienced OSD Process Lead / SME to support a greenfield Oral Solid Dosage (OSD) manufacturing facility for our client in Japan.

 

Key Responsibilities

  • Act as OSD Process SME & Discipline Lead across all project phases
  • Define and review OSD process concepts (granulation, blending, compression, coating, encapsulation)
  • Support process technology selection (batch vs continuous)
  • Develop/review PFDs, mass balances, URSs, and process descriptions
  • Lead OSD process equipment strategy and vendor engagement
  • Serve as technical interface with primary equipment vendors
  • Participate in FAT/SAT, commissioning, qualification, and start-up
  • Ensure alignment with GMP, automation, containment, and utilities

 

Essential Experience

  • 10+ years in pharmaceutical OSD manufacturing
  • Strong greenfield project experience
  • Proven leadership of OSD process equipment
  • Hands-on experience with GMP, EPC/EPCM projects

 

Highly Preferred

  • Direct experience with Glatt OSD process equipment, including:
    • Vendor interface
    • URS and documentation review
    • FAT/SAT participation
    • GMP facility integration

 

Consultant

Micia Bellamy