Process Engineer
Aquestive Therapeutics
August 31, 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, evaluate literature/vendors, propose, develop/execute projects) using Management of Change (MOCs).
- Act as Technical SME to investigate and resolve process/equipment issues.
- Monitor process attributes/parameters, identify trends, and drive continuous improvement.
- Provide training support as required.
- Support development of required cleaning processes for equipment trains.
- Prepare documentation for new processes/improvements: MOCs, risk assessments, batch records, engineering studies (ES), and SOPs.
- Prepare work orders and documents including MOCs, design specs (DS), URS, system spec docs (SSD), and FMEA.
- Lead technology transfer and scale-up: determine parameters at pilot/commercial scale, assess variability on CQAs, implement control strategy into batch records, finalize QTPP.
- Represent Engineering SME in product development teams; support deviation investigations and CAPAs; manage outside contractors; work independently and in cross-functional teams; interact with regulators, vendors, and consultants.
Qualifications:
- 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 mixing/blending, thin film coating, packaging/web handling, and liquid dispensing.
- Proficient with MS Office/Outlook/Word/Excel/PowerPoint/MS Teams.
- Knowledge of cGMPs, CAPA, root-cause analysis, risk assessment.
- Project management experience (capital requests; MS Project, Wrike, or similar).
- Strong written/verbal communication and ability to adapt to changing priorities.
Benefits: bonus eligibility; health care/insurance; retirement benefits; paid holidays, vacation, and sick days.
Application instructions: Final candidate must complete a drug test and background check before employment.
Responsibilities:
- Lead new and continuous process improvement projects (identify opportunities, evaluate literature/vendors, propose, develop/execute projects) using Management of Change (MOCs).
- Act as Technical SME to investigate and resolve process/equipment issues.
- Monitor process attributes/parameters, identify trends, and drive continuous improvement.
- Provide training support as required.
- Support development of required cleaning processes for equipment trains.
- Prepare documentation for new processes/improvements: MOCs, risk assessments, batch records, engineering studies (ES), and SOPs.
- Prepare work orders and documents including MOCs, design specs (DS), URS, system spec docs (SSD), and FMEA.
- Lead technology transfer and scale-up: determine parameters at pilot/commercial scale, assess variability on CQAs, implement control strategy into batch records, finalize QTPP.
- Represent Engineering SME in product development teams; support deviation investigations and CAPAs; manage outside contractors; work independently and in cross-functional teams; interact with regulators, vendors, and consultants.
Qualifications:
- 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 mixing/blending, thin film coating, packaging/web handling, and liquid dispensing.
- Proficient with MS Office/Outlook/Word/Excel/PowerPoint/MS Teams.
- Knowledge of cGMPs, CAPA, root-cause analysis, risk assessment.
- Project management experience (capital requests; MS Project, Wrike, or similar).
- Strong written/verbal communication and ability to adapt to changing priorities.
Benefits: bonus eligibility; health care/insurance; retirement benefits; paid holidays, vacation, and sick days.
Application instructions: Final candidate must complete a drug test and background check before employment.