Process Engineer

Stark Pharma Solutions Inc; Cincinnati (OH); On-site; USD 85,000 - 105,000; 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. The role focuses on technology transfer, process optimization, troubleshooting, scale-up, and manufacturing readiness.

You will collaborate with cross-functional teams, analyze process performance, prepare technical documentation, and ensure compliance with regulatory requirements while advancing OSD manufacturing capabilities.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a 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

Troubleshooting

Data analysis

Education

Bachelor's degree in Engineering or Life Sciences

Job description

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India.

We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Process Engineer
Location: Ohio
Duration: Long Term

Job Overview

We are seeking an experienced Process Engineer to support Oral Solid Dosage (OSD) manufacturing operations in a cGMP pharmaceutical environment.

The role will focus on technology transfer, process optimization, troubleshooting, scale-up, and manufacturing readiness activities.

Key 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.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a 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.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.