- Location
- Yamagata, Yamagata
- Workplace
- Onsite
- Type
- Full-time
- Department
- Engineering
- Seniority
- Lead
- Closing date
- Today
- Source
- Vincere
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
Skills
GMP