Process Engineer – Pharmaceutical Manufacturing

Job Title: Process Engineer Pharmaceutical Manufacturing

Location: Ohio 100% Onsite

Duration: 6 Months Contract

Rate: $45 - $52/hr W2

Experience: 5+ Years

Position Overview:

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 candidates will have strong experience in pharmaceutical process validation, technology transfer, scale-up activities, manufacturing support, and batch documentation. The engineers will serve as technical leads across development-to-commercialization activities and work closely with Manufacturing, Quality, Process Development, and external partners.

Key Responsibilities:

• Lead pharmaceutical process scale-up and technology transfer activities
• Support process validation activities for commercial manufacturing
• Provide technical support during manufacturing campaigns and product launches
• Develop and review manufacturing batch records and process documentation
• Support development-to-commercialization activities for small-molecule products
• Partner with Manufacturing, Quality, Development, and external technical teams
• Identify process risks and develop appropriate mitigation strategies
• Support process improvements, CAPAs, and lifecycle management activities
• Analyze process data and support troubleshooting and root-cause investigations
• Provide technical guidance during product launches and manufacturing readiness activities
• Support validation campaigns and ensure successful execution of manufacturing processes
• Maintain appropriate technical documentation and ensure alignment with quality requirements
• Manage multiple projects and priorities in a fast-paced pharmaceutical manufacturing environment

Required / Preferred Qualifications:

• Bachelor's degree in Engineering, Chemistry, Pharmacy, or a related scientific discipline required
• 5+ years of relevant experience in pharmaceutical process engineering, process development, validation, or manufacturing support
• Strong experience with pharmaceutical process validation
• Experience with technology transfer and process scale-up activities
• Experience supporting manufacturing operations and commercial manufacturing readiness
• Experience with batch record development and manufacturing documentation
• Strong problem-solving, analytical, leadership, and communication skills
• Ability to work independently and manage multiple priorities in a fast-paced environment
• Experience with oral solid dosage forms and/or liquid pharmaceutical products is preferred
• Small-molecule pharmaceutical manufacturing experience is preferred
• Experience with Minitab or statistical analysis is a plus
• Experience supporting commercial product launches is a plus
• Experience with process improvements, CAPAs, and lifecycle management is preferred