Pharma Process Scale-Up Engineer for Tech Transfer

Aquestive Therapeutics; Portage (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Aquestive Therapeutics in Portage, IN seeks a senior engineer to lead product technology transfer and scale-up for LCO (Lotion, Cream, Ointment) pharmaceutical products across manufacturing facilities. You will drive process improvements, act as SME, and ensure robust documentation and regulatory readiness.

The role requires a 4-year engineering degree (Chemical/Mechanical), 5–7 years pharma process development/manufacturing experience, and strong skills in project management, cGMPs, and

Qualifications

• 4-year degree in Chemical or Mechanical Engineering or equivalent pharma experience.
• 5-7 years pharmaceutical process development/manufacturing experience.
• Expertise in troubleshooting manufacturing processes (mixing/blending, thin film coating, packaging, web handling, liquid dispensing).
• Proficiency with Outlook, Word, Excel, PowerPoint, MS Teams.
• Knowledge of cGMPs, CAPA, root-cause analysis, risk assessment and investigation tools.
• Experience in leading capital funding requests and project management software.

Responsibilities

• Lead New and Continuous Process Improvement Projects, including identifying opportunities, researching literature and vendors for new technologies, preparing proposals, and executing projects per MOC methodologies.
• Support day-to-day manufacturing operations as Technical SME by investigating and resolving process issues.
• Perform process monitoring of attributes and parameters, identifying trends and actions to improve the process and product.
• Provide training support as required.
• Prepare documentation for new processes and improvements including MOCs, risk assessments, batch records, ES and SOPs.
• Prepare WOs, MOCs, DS, URS, SSD, FMEA documents for new systems/processes.

Skills

Process troubleshooting

Communication skills

Project management

cGMP knowledge

Office software proficiency

Education

Chemical or Mechanical Engineering degree

Tools

MS Project

Wrike

Job description

Aquestive Therapeutics in Portage, IN seeks a senior engineer to lead product technology transfer and scale-up for LCO (Lotion, Cream, Ointment) pharmaceutical products across manufacturing facilities. You will drive process improvements, act as SME, and ensure robust documentation and regulatory readiness.

The role requires a 4-year engineering degree (Chemical/Mechanical), 5–7 years pharma process development/manufacturing experience, and strong skills in project management, cGMPs, and