Process Engineer

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 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 (MOCs) 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. Identifying trends and appropriate actions to continuously improve the process and product.

* Provides training support as required.

* Supports development of required cleaning processes for equipment trains.

* Prepares documentation for new processes and process improvements including Management of Change (MOCs), Risk Assessments, Batch Records, Engineering Studies (ES) and Standard Operating Procedures (SOPs)

* Prepare Work Orders (WOs), Management of Change (MOCs), Design Specifications (DS), User Requirements Specifications (URS), System Specifications Documents (SSD), Failure Mode and Effect Analysis documents (FMEA) for new system/ processes.

* Develops a plan and leads product technology transfer and scale-up.

* Determines process parameters at Pilot and Commercial Scale.

* Evaluates process parameter variability on Critical Quality Attributes.

* Establishes the product manufacturing control strategy and implements into Batch Records.

* Finalizes the QTPP (Quality Target Product Profile).

* Represents 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.

* Able to perform all duties efficiently and independently with minimal supervision.

* Able to 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.

* Able to interact with management and peers within the department, within the plant, within the organization and outside regulatory agencies. The individual must also 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…