Project Engineer Controls Specialist

4 days ago

Portage, Indiana, United States Aquestive Therapeutics Full time
Job Summary:

Aquestive Therapeutics is seeking a highly skilled Project Engineer Controls Specialist to provide engineering, maintenance, and project support to new and existing systems, utilities, and equipment associated with the manufacturing of thin film pharmaceutical products.

Key Responsibilities:
  • Technical Expertise: Support day-to-day manufacturing operations as a Technical Subject Matter Expert (SME) by investigating and resolving production-related issues involving critical utilities, clean rooms, and equipment/systems.
  • Project Leadership: 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.
  • Documentation and Training: 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.
  • Deviation Investigations: Support deviation investigations to identify root causes and define corrective and preventive actions (CAPAs).
  • Standard Operating Procedures: Develop and/or modify SOPs (Standard Operating Procedure) as required for new or continuous improvement initiatives.
  • Contractor Management: Work with and manage outside contractors to provide support to projects.
  • System Enhancements: 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.
  • Team Collaboration: 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.
  • Communication and Interactions: 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:
  • Education: Minimum 4-year degree in Electrical, or Computer Engineering; or equivalent experience.
  • Experience: Minimum of 3 years of related experience; pharmaceutical manufacturing/maintenance experience required.
  • Knowledge and Skills: 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.
  • Communication and Adaptability: Strong communication skills, both written and verbal, and ability to adapt to changing priorities working both independently and collaboratively with teams, when required.
  • Technical Skills: 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.
  • Confidentiality: 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:
  • Mental and Physical Demands: 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.
  • Extended Hours: This position will provide 24-hour support to manufacturing and may be required to work extended hours to support operations or projects.

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