ABOUT COMPANY:
Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.
Process Engineer - Oral Solid Dosage (Granulation, Compression, Coating)
JOB SUMMARY:
Our client, a mid-size pharmaceutical CDMO, is seeking an experienced Process Engineer to support Oral Solid Dosage manufacturing operations in a cGMP environment, with a strong emphasis on technology transfer. This role leads and supports the transfer of products and processes from development, pilot or external manufacturing sites into commercial manufacturing, ensuring process knowledge is transferred effectively and manufacturing readiness is achieved.
This is a hands-on OSD role. Candidates whose experience is in medical device, software validation, or non-pharmaceutical manufacturing will not be a fit.
RESPONSIBILITIES:
- Coordinate cross-functional technology transfer activities from development, pilot or external sites into commercial manufacturing
- Support scale-up efforts and drive execution of engineering, validation and manufacturing readiness activities
- Perform process optimization and troubleshoot manufacturing issues on OSD unit operations
- Evaluate process performance data and author technical protocols and reports
- Support process characterization and Process Performance Qualification (PPQ) activities
- Manage change controls and lead deviation investigations and CAPAs
- Partner with Manufacturing, Quality Assurance, Engineering, MS&T and Regulatory teams
QUALIFICATIONS:
- Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences or related discipline
- Hands-on experience with OSD unit operations: blending, granulation, milling, compression, encapsulation, coating and packaging
- Demonstrated technology transfer experience into commercial manufacturing
- Experience supporting PPQ and process characterization
- Working knowledge of cGMP requirements and commercial manufacturing operations
- Experience with change control, deviation investigation and CAPA
- Strong technical writing and problem-solving skills
- Must be legally authorized to work in the United States without sponsorship now or in the future
- W2 employment only
HOW TO APPLY:
Please send your resume to deepika.b@starkpharma.com . In your email, please include your current location, your hourly rate expectation on W2, and your availability to start.