Process Engineer

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

About the Role

The Process Engineer will provide technical leadership across development-to-commercialization activities, including process scale-up, technology transfer, Process Performance Qualification (PPQ), Continued Process Verification (CPV), and commercial launch support.

This position works closely with Formulation and Process Development, Manufacturing, Quality, Regulatory Affairs, and external manufacturing partners. The successful candidate must be able to independently prioritize multiple projects, investigate complex process problems, and provide hands-on support in a fast-paced GMP manufacturing environment.

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.

Required 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.

Preferred Qualifications

• Direct finished drug product manufacturing experience, particularly oral solid dosage forms such as tablets and capsules, or pharmaceutical liquid products.
• Small-molecule pharmaceutical manufacturing experience.
• Experience working with formulation or process development teams on engineering batches, CPP/CQA establishment, Design of Experiments, or process optimization.
• Continued Process Verification experience, including CPP/CQA trending, process capability analysis, statistical analysis, or control-strategy improvements.
• Experience using Minitab or comparable statistical analysis software.
• Experience supporting commercial product launches, process improvements, CAPAs, and product lifecycle management.
• Experience collaborating with Regulatory Affairs on NDA/ANDA documentation, validation reports used in regulatory filings, FDA responses, or inspection support.

Ameri-Partners is an equal opportunity employer. Qualified applicants will be considered without regard to any characteristic protected by applicable law.