OSD Process Engineer: Tech Transfer & Granulation/Coating

Stark Pharma Solutions Inc; Cleveland (OH); Presencial; USD 75 000 - 110 000; Tempo integral

Resumo da oferta

Stark Pharma Solutions Inc in the United States 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 hands-on role leads transfer of products and processes from development to commercial manufacturing, ensuring readiness and knowledge transfer.

The ideal candidate has a solid background in blending, granulation, milling, compression, encapsulation, coating and packaging, plus

Qualificações

• 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.
• 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.
• W2 employment only.

Responsabilidades

• 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 PPQ activities.
• Manage change controls and lead deviation investigations and CAPAs.
• Partner with Manufacturing, Quality Assurance, Engineering, MS&T and Regulatory teams.

Conhecimentos

Technical writing

Problem-solving

Cross-functional collaboration

Process optimization

Formação académica

Bachelor's degree in Chemical Engineering or Pharmaceutical Sciences

Descrição da oferta de emprego

Stark Pharma Solutions Inc in the United States 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 hands-on role leads transfer of products and processes from development to commercial manufacturing, ensuring readiness and knowledge transfer.

The ideal candidate has a solid background in blending, granulation, milling, compression, encapsulation, coating and packaging, plus