Pharma Process Engineer: Scale-Up & Commercialization

Ameri-partners; Columbus (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Ameri-Partners in Columbus, Ohio is hiring two full-time Process Engineers to support small-molecule drug product commercialization, process validation, technology transfer, and commercial manufacturing readiness.

The engineers will provide technical leadership across development-to-commercialization activities, including PPQ and CPV, and will work closely with Manufacturing, Quality, Regulatory Affairs, and external partners.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Pharmacy, or a related scientific discipline.
• Hands-on pharmaceutical process validation or PPQ experience.
• Experience with pharmaceutical technology transfer, process scale-up, commercial manufacturing support, and batch record development.
• Ability to explain the PPQ activities personally owned or executed, including protocols, sampling, deviations, acceptance criteria, and reports.
• Experience authoring or reviewing Manufacturing Batch Records and supporting quality investigations.
• Strong technical leadership, collaboration, troubleshooting, and problem-solving skills.
• Ability to work independently and manage priorities across multiple projects.

Responsibilities

• Lead or provide substantial technical ownership of pharmaceutical process validation and PPQ activities.
• Author or review PPQ protocols, acceptance criteria, sampling plans, execution documentation, deviations, and final validation reports.
• Support process scale-up and technology transfer from development, pilot-scale, or sending-site operations into commercial manufacturing.
• Partner with formulation and process development teams during development batches, engineering batches, process optimization, and commercial readiness activities.
• Evaluate critical process parameters and critical quality attributes (CPPs/CQAs) and support development of robust manufacturing control strategies.
• Author and review Manufacturing Batch Records, technology transfer documents, process instructions, protocols, technical reports, and supporting GMP documentation.
• Provide technical support during manufacturing campaigns, PPQ execution, product launches, and lifecycle initiatives.
• Lead or support process investigations, root-cause analysis, CAPAs, process improvements, and manufacturing risk mitigation.
• Collaborate with internal teams, contract manufacturing organizations, and other external partners to ensure successful project execution.

Education

Bachelor’s degree in Engineering, Chemistry, Pharmacy, or a related scientific discipline

Job description

Ameri-Partners in Columbus, Ohio is hiring two full-time Process Engineers to support small-molecule drug product commercialization, process validation, technology transfer, and commercial manufacturing readiness.

The engineers will provide technical leadership across development-to-commercialization activities, including PPQ and CPV, and will work closely with Manufacturing, Quality, Regulatory Affairs, and external partners.