Project Engineer Controls at Aquestive Therapeutics

Job Summary:

Responsible for providing engineering, maintenance, and project support to new and existing systems, utilities, and equipment associated with the manufacturing of thin film pharmaceutical products at Aquestive Therapeutics Manufacturing facilities in Portage, IN.

Responsibilities:

• Support day-to-day manufacturing operations as Technical Subject Matter Expert (SME) by investigating and resolving production-related issues involving critical utilities, clean rooms, and equipment/ systems.
• Lead New and Continuous Improvement Projects, including identification of opportunities, researching literature and vendors, preparing/presenting proposals, developing/executing projects, while following appropriate change control methodologies.
• 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), Site Acceptance Testing documents (SAT) for system/ process improvements, planned and corrective maintenance, and new system/ processes.
• Provide training support as required on new or existing equipment and systems.
• Support deviation investigations to identify root causes and define corrective and preventive actions (CAPAs).
• Develop and/or modify SOPs (Standard Operating Procedure) as required for new or continuous improvement initiatives.
• Work with and manage outside contractors to provide support to projects.
• Responsible for leading enhancements and upgrades of manufacturing related systems to maintain production capability. Follows and enhances SOPs, batch records and other documentation which guide performance of activities.
• 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 Electrical, or Computer Engineering; or equivalent experience.
• Minimum of 3 years of related experience; pharmaceutical manufacturing/maintenance experience required.
• Knowledge and experience in cGMPs, CAPA, root-cause analysis, risk assessment and investigation tools and techniques.
• Knowledge and experience in project management, including development of capital funding requests and project management software (MS Project or similar).
• Expertise in troubleshooting production equipment/ systems.
• PC literate with standard office application (Word, Excel, PowerPoint) competency.
• Experience with maintenance and administration of both Windows-based and industrial (e.g., PLC) computer networks.
• Strong communication skills, both written and verbal, and ability to adapt to changing priorities working both independently and collaboratively with teams, when required.
• Experience with Automating processes and equipment.
• Knowledge and experience with PLC programming software such as Allen Bradley RS Logix and Siemens SIMATIC.
• Knowledge and experience with HMI (Human Machine Interface) communication tools such as FactoryTalk Studio and SIMATIC WinCC.
• Capable of troubleshooting machine vision systems.
• Experience reading/reviewing/ creating electrical schematics for machine control panels. Ability to use AutoCAD a plus.
• 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 to 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 to manufacturing and may be required to work extended hours to support operations or projects.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing.  Please Note:  Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.