Process Engineer - OSD Tech Transfer & Scale-Up

Stark Pharma Solutions Inc; Cincinnati (OH); On-site; USD 80,000 - 115,000; Full time

Job summary

Stark Pharma Solutions Inc. in Ohio seeks an experienced Process Engineer to support Oral Solid Dosage (OSD) manufacturing in a cGMP environment. You will drive technology transfer, optimize processes, troubleshoot manufacturing issues, and contribute to scale-up and readiness activities.

In this role you will collaborate with Manufacturing, Quality, Engineering, MS&T, and Regulatory teams to ensure compliant, robust processes and thorough documentation throughout PPQ and change-control programs.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• Experience as a Process Engineer in pharmaceutical manufacturing.
• Strong experience with OSD manufacturing processes.
• Hands-on experience with technology transfer activities.
• Experience supporting process scale-up and optimization.
• Experience with PPQ and process characterization.
• Experience with deviations, CAPAs, and change controls.
• Strong understanding of cGMP and commercial manufacturing operations.
• Strong technical writing, communication, and problem-solving skills.

Responsibilities

• Support technology transfer of products and processes into commercial manufacturing.
• Coordinate technology transfer activities with cross-functional teams.
• Support process scale-up and manufacturing readiness activities.
• Optimize manufacturing processes and troubleshoot production issues.
• Analyze process performance and manufacturing data.
• Prepare technical protocols, reports, and process documentation.
• Support process characterization and PPQ activities.
• Manage change controls and support deviation investigations and CAPAs.
• Work with Manufacturing, Quality, Engineering, MS&T, and Regulatory teams.
• Ensure processes comply with cGMP requirements.
• Support OSD manufacturing processes including blending, granulation, milling, compression, encapsulation, coating, and packaging.

Skills

OSD manufacturing processes

Technology transfer

Process optimization

CAPA management

cGMP knowledge

Technical writing

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

Stark Pharma Solutions Inc. in Ohio seeks an experienced Process Engineer to support Oral Solid Dosage (OSD) manufacturing in a cGMP environment. You will drive technology transfer, optimize processes, troubleshoot manufacturing issues, and contribute to scale-up and readiness activities.

In this role you will collaborate with Manufacturing, Quality, Engineering, MS&T, and Regulatory teams to ensure compliant, robust processes and thorough documentation throughout PPQ and change-control programs.