Process Engineer

Aquestive Therapeutics • Portage, IN

45d • Onsite

About The Position

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. This role involves leading process improvement projects, supporting daily manufacturing operations as a Technical Subject Matter Expert (SME), performing process monitoring, and developing necessary documentation for new processes and improvements. The individual will also be involved in establishing manufacturing control strategies, representing Engineering in Product Development Teams, and supporting deviation investigations. Additionally, the role requires managing outside contractors and working effectively within a team environment with multi-functional groups, management, peers, and external agencies, vendors, and consultants.

Requirements

• 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.

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.

Benefits

• bonus eligibility
• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level