Process Engineer
Aquestive Therapeutics
17 days ago
On-site
Portage, IN
Operations
Job Summary:
Responsible for leading product technology transfer and process scale-up for new and existing thin film and dispensed LCO (Lotion, Cream, Ointment) pharmaceutical products at manufacturing facilities in Portage, IN.
Responsibilities:
- Lead new and continuous process improvement projects, including opportunity identification, literature/vendor research, proposals, and execution, following Management of Change (MOC) methodologies.
- Serve as Technical SME for day-to-day manufacturing by investigating and resolving process/equipment/system issues.
- Perform process monitoring of attributes and parameters; identify trends and actions to continuously improve process and product.
- Provide training support as required.
- Support development of cleaning processes for equipment trains.
- Prepare documentation for new processes/process improvements: MOCs, risk assessments, batch records, engineering studies (ES), and SOPs.
- Prepare Work Orders (WOs), MOCs, Design Specifications (DS), URS, System Specifications Documents (SSD), and FMEA for new systems/processes.
- Develop and lead product technology transfer and scale-up (pilot to commercial), including setting parameters, evaluating variability on CQAs, establishing control strategy and implementing into batch records, and finalizing QTPP.
- Represent Engineering SME in product development teams; support deviation investigations and CAPAs.
- Work with and manage outside contractors.
Qualifications:
- Minimum 4-year degree in Chemical (preferred) or Mechanical Engineering, or equivalent pharmaceutical experience.
- 5–7 years related experience; pharmaceutical process development/manufacturing preferred.
- Expertise troubleshooting manufacturing processes (mixing/blending, thin film coating, packaging/web handling, liquid dispensing).
- PC literate (Outlook, Word, Excel, PowerPoint, MS Teams).
- Knowledge of cGMPs, CAPA, root-cause analysis, and risk assessment/investigation tools.
- Knowledge of project management (capital funding requests; MS Project, Wrike or similar).
- Strong written/verbal communication; able to work independently and collaboratively.
Application instructions:
- Final candidate must complete a drug test and background check prior to employment.
Responsible for leading product technology transfer and process scale-up for new and existing thin film and dispensed LCO (Lotion, Cream, Ointment) pharmaceutical products at manufacturing facilities in Portage, IN.
Responsibilities:
- Lead new and continuous process improvement projects, including opportunity identification, literature/vendor research, proposals, and execution, following Management of Change (MOC) methodologies.
- Serve as Technical SME for day-to-day manufacturing by investigating and resolving process/equipment/system issues.
- Perform process monitoring of attributes and parameters; identify trends and actions to continuously improve process and product.
- Provide training support as required.
- Support development of cleaning processes for equipment trains.
- Prepare documentation for new processes/process improvements: MOCs, risk assessments, batch records, engineering studies (ES), and SOPs.
- Prepare Work Orders (WOs), MOCs, Design Specifications (DS), URS, System Specifications Documents (SSD), and FMEA for new systems/processes.
- Develop and lead product technology transfer and scale-up (pilot to commercial), including setting parameters, evaluating variability on CQAs, establishing control strategy and implementing into batch records, and finalizing QTPP.
- Represent Engineering SME in product development teams; support deviation investigations and CAPAs.
- Work with and manage outside contractors.
Qualifications:
- Minimum 4-year degree in Chemical (preferred) or Mechanical Engineering, or equivalent pharmaceutical experience.
- 5–7 years related experience; pharmaceutical process development/manufacturing preferred.
- Expertise troubleshooting manufacturing processes (mixing/blending, thin film coating, packaging/web handling, liquid dispensing).
- PC literate (Outlook, Word, Excel, PowerPoint, MS Teams).
- Knowledge of cGMPs, CAPA, root-cause analysis, and risk assessment/investigation tools.
- Knowledge of project management (capital funding requests; MS Project, Wrike or similar).
- Strong written/verbal communication; able to work independently and collaboratively.
Application instructions:
- Final candidate must complete a drug test and background check prior to employment.