Process Engineer – Pharma

Process Engineer Pharmaceutical Manufacturing

Location:

Ohio 100% Onsite

Duration: 6-Month Contract

Rate: $45 $ 52/hr W2

Experience:

5+ Years

We are seeking experienced Process Engineers to support pharmaceutical manufacturing activities across process scale-up, technology transfer, process validation, manufacturing support, and commercial manufacturing readiness.

The ideal candidate will have strong experience in pharmaceutical process validation, technology transfer, scale-up, manufacturing operations, and batch documentation, with the ability to provide technical leadership throughout development and commercialization activities.

This role will work closely with Manufacturing, Quality, Process Development, and external technical teams to ensure successful process implementation, validation, and ongoing manufacturing support.

• Lead process scale-up and technology transfer activities for pharmaceutical products.
• Support process validation and validation campaigns for commercial manufacturing.
• Provide technical support during manufacturing campaigns, product launches, and process implementation.
• Develop, review, and maintain manufacturing batch records and technical documentation.
• Support the transition of products from development through commercialization.
• Collaborate with Manufacturing, Quality, Process Development, and external partners to resolve technical issues.
• Identify process risks and develop appropriate risk mitigation strategies.
• Support process improvements, CAPAs, and product/process lifecycle management.
• Analyze process data and support troubleshooting, root-cause investigations, and continuous improvement.
• Provide technical guidance for manufacturing readiness and commercial product launches.
• Support successful execution of validation activities and ensure manufacturing processes meet established requirements.
• Maintain accurate technical documentation in accordance with applicable quality and regulatory requirements.
• Manage multiple projects and priorities in a fast-paced pharmaceutical manufacturing environment.

• Bachelor's degree in Engineering, Chemistry, Pharmacy, or a related scientific discipline.
• 5+ years of relevant experience in pharmaceutical process engineering, process development, validation, or manufacturing support.
• Strong experience with pharmaceutical process validation.
• Hands-on experience with technology transfer and process scale-up.
• Experience supporting pharmaceutical manufacturing operations and commercial manufacturing readiness.
• Experience developing or reviewing manufacturing batch records and process documentation.
• Strong analytical, problem-solving, communication, and project-management skills.
• Ability to work independently while managing multiple priorities in a fast-paced environment.

• Experience with small-molecule pharmaceutical manufacturing.
• Experience with oral solid dosage (OSD) and/or liquid pharmaceutical products.
• Experience with Minitab and statistical analysis.
• Experience supporting commercial product launches.
• Experience with process improvement, CAPA, and lifecycle management.
• Experience working cross-functionally with Manufacturing, Quality, Process Development, and technical teams.