Process Engineer

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

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: Dayton, OH

Duration: Long Term

Job Overview

We are seeking Process Engineers to support pharmaceutical process scale-up, technology transfer, process validation, and commercial manufacturing readiness for a portfolio of small molecule products. The ideal candidate will provide technical leadership across development-to-commercialization activities, supporting manufacturing processes, batch documentation, validation campaigns, and risk mitigation initiatives.

Key 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.

Required Qualifications

• Bachelor s degree in Engineering, Chemistry, Pharmacy, or a related scientific discipline.
• 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.
• Ability to work independently in a fast-paced environment.
• Experience with oral solid dosage forms and liquid products is preferred.
• Experience with Minitab or statistical analysis is a plus.

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