Pharma Process Engineer: Scale-Up & Tech Transfer Lead

Stark Pharma Solutions Inc; Dayton (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc. in Dayton, OH, is seeking a Process Engineer to lead development-to-commercialization activities for small molecule manufacturing.

You will support process development, scale-up, technology transfer, and validation campaigns to ensure readiness for product launches. The role requires expertise in process validation, batch records, and cross-functional collaboration with Manufacturing, Quality, and Development teams.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmacy or related field.
• Experience with pharmaceutical process validation.
• Experience with technology transfer, process scale-up, and manufacturing support.
• Experience with batch record development.
• Experience with small molecule pharmaceutical manufacturing.
• Experience supporting commercial manufacturing readiness and product launches.
• Strong process development and optimization experience.
• Experience with risk mitigation, CAPA, and process improvement activities.
• Strong leadership, collaboration, problem-solving and communication skills.

Responsibilities

• Support pharmaceutical process development, scale-up, and optimization activities.
• Provide technical support for commercial manufacturing operations.
• Develop and support batch records and manufacturing documentation.
• Support technology transfer activities from development to commercial manufacturing.
• Support process validation activities and validation campaigns.
• Drive commercial manufacturing readiness for product launches.
• Identify process risks and support CAPA and risk mitigation activities.
• Support process improvements and lifecycle management initiatives.
• Collaborate with Manufacturing, Quality, Development, and external partners.
• Provide technical guidance and troubleshooting support during manufacturing activities.

Skills

Process development

Process validation

Tech transfer

Scale-up

CAPA & risk

Leadership

Minitab

Education

Bachelor's degree in Engineering/Science

Tools

Minitab

Job description

Stark Pharma Solutions Inc. in Dayton, OH, is seeking a Process Engineer to lead development-to-commercialization activities for small molecule manufacturing.

You will support process development, scale-up, technology transfer, and validation campaigns to ensure readiness for product launches. The role requires expertise in process validation, batch records, and cross-functional collaboration with Manufacturing, Quality, and Development teams.