Process Engineer
Aquestive Therapeutics
August 29, 2026
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 (identify opportunities, research literature/vendors, propose, develop/execute) following appropriate Management of Change (MOCs).
- Serve as Technical Subject Matter Expert (SME) for day-to-day manufacturing by investigating and resolving process and equipment/system issues.
- Perform process monitoring of attributes/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/improvements including MOCs, risk assessments, batch records, engineering studies (ES), and SOPs.
- Prepare work orders, MOCs, design specifications (DS), user requirements (URS), system specifications (SSD), and FMEA documents for new systems/processes.
- Develop and lead product technology transfer and scale-up, including pilot/commercial parameter definition, evaluation of variability on critical quality attributes, implementing control strategy into batch records, and finalizing QTPP.
- Represent Engineering SME in product development teams.
- Support deviation investigations; define 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).
- Proficient in Outlook, Word, Excel, PowerPoint, MS Teams.
- Knowledge of cGMPs, CAPA, root-cause analysis, risk assessment, and investigation tools.
- Knowledge of project management (capital funding requests; MS Project/WRIKE or similar).
- Strong written/verbal communication; able to adapt to changing priorities and work independently and collaboratively.
Benefits/Instructions:
- Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
- 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 (identify opportunities, research literature/vendors, propose, develop/execute) following appropriate Management of Change (MOCs).
- Serve as Technical Subject Matter Expert (SME) for day-to-day manufacturing by investigating and resolving process and equipment/system issues.
- Perform process monitoring of attributes/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/improvements including MOCs, risk assessments, batch records, engineering studies (ES), and SOPs.
- Prepare work orders, MOCs, design specifications (DS), user requirements (URS), system specifications (SSD), and FMEA documents for new systems/processes.
- Develop and lead product technology transfer and scale-up, including pilot/commercial parameter definition, evaluation of variability on critical quality attributes, implementing control strategy into batch records, and finalizing QTPP.
- Represent Engineering SME in product development teams.
- Support deviation investigations; define 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).
- Proficient in Outlook, Word, Excel, PowerPoint, MS Teams.
- Knowledge of cGMPs, CAPA, root-cause analysis, risk assessment, and investigation tools.
- Knowledge of project management (capital funding requests; MS Project/WRIKE or similar).
- Strong written/verbal communication; able to adapt to changing priorities and work independently and collaboratively.
Benefits/Instructions:
- Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
- Final candidate must complete a drug test and background check prior to employment.