Process Engineer

About the role

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 Aquestive Therapeutics Manufacturing facilities in Portage, IN.

Responsibilities

• Lead new and continuous process improvement projects, including identification of opportunities, researching literature and vendors for new technologies, preparing/presenting proposals, developing/executing projects, while following appropriate Management of Change (MOC) methodologies.
• Support day-to-day manufacturing operations as Technical Subject Matter Expert (SME) by investigating and resolving process-related issues involving the manufacturing process or equipment/systems.
• Perform process monitoring of identified attributes and process parameters; identify trends and appropriate actions to continuously improve the process and product.
• Provide training support as required.
• Support development of required cleaning processes for equipment trains.
• Prepare documentation for new processes and process improvements including Management of Change (MOC), Risk Assessments, Batch Records, Engineering Studies (ES) and Standard Operating Procedures (SOPs).
• Prepare Work Orders (WOs), Management of Change (MOC), Design Specifications (DS), User Requirements Specifications (URS), System Specifications Documents (SSD), Failure Mode and Effect Analysis documents (FMEA) for new systems/processes.
• Develop a plan and lead product technology transfer and scale-up.
• Determine process parameters at Pilot and Commercial Scale.
• Evaluate process parameter variability on Critical Quality Attributes.
• Establish the product manufacturing control strategy and implement into Batch Records.
• Finalize the QTPP (Quality Target Product Profile).
• Represent Engineering Subject Matter Expert (SME) in Product Development Teams.
• Support deviation investigations to identify root causes and define corrective and preventive actions (CAPAs).
• Work with and manage outside contractors to provide support to projects.
• Perform all duties efficiently and independently with minimal supervision.
• Work within and lead in a team environment, consisting of multi-functional groups, to achieve a common goal, while promoting teamwork, timeliness, accuracy and compliance in all activities.
• Interact with management and peers within the department, within the plant, within the organization and outside regulatory agencies; interact with vendors, sub-contractors and consultants on a routine basis.

Qualifications

• Minimum 4-year degree in Chemical (preferred) or Mechanical Engineering, or equivalent pharmaceutical experience.
• 5–7 years of related experience; pharmaceutical process development/manufacturing experience preferred.
• Expertise in troubleshooting manufacturing processes, ideally with mixing and blending systems, thin film coating, packaging and web handling, and liquid dispensing.
• PC literate with standard office applications (Outlook, Word, Excel, PowerPoint, MS Teams) competency.
• Knowledge and experience in cGMPs, CAPA, root-cause analysis, risk assessment and investigation tools and techniques.
• Knowledge and experience in project management, including leading and development of capital funding requests and project management software (MS Project, WRIKE or similar).
• Strong communication skills, both written and verbal, and ability to adapt to changing priorities working both independently and collaboratively with teams, when required.
• This individual may become familiar with proprietary and confidential information in the performance of routine duties. Disclosure of such proprietary and confidential information may have a serious detrimental effect on Aquestive’s business and may result in disciplinary or legal consequences.

Working Environment / Physical Requirements

This position requires concentrated effort in recording, evaluating and transcribing data, as well as computer work, which can cause mental and/or eye fatigue. The work is performed in a clean environment. This position will provide 24-hour support for manufacturing and may be required to work extended hours to support operations or projects.

Benefits

• Bonus eligibility
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays, vacation, and sick days