Lead Process Engineer (SME)
Job Summary
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
Required Experience:
IC
About Company
With over 19 years of experience and 5 global offices, we have the knowledge and experience to deliver the highest quality of service globally. To be the global recruitment partner of choice, delivering the highest quality of service and driving cost effectiveness for our clients. N ... View more