Equipment Automation Engineer II

Automation Engineer II

Core Hours

Monday - Friday, 8:00 am - 5:00 pm, on-call as needed

Purpose and Scope

The Automation Engineer II owns the necessary actions and processes and provides technical support for installation, day-to-day activities, upgrades, and maintaining compliance with new and existing automation equipment and systems at Tolmar's manufacturing sites in Colorado (Fort Collins and Windsor). Technical support includes but is not limited to; design, troubleshooting, reporting and data requests, on-call support, programming, generating lifecycle documentation, commissioning and qualification activities, managing change controls, and supporting / managing projects.

Essential Duties & Responsibilities

• Provide technical support and identify and implement process improvements on automation equipment and systems (including production equipment, utilities systems, and building automation and controls systems).
• Perform necessary functions to monitor and maintain automation equipment and systems in a validated state per regulatory requirements.
• Initiate, assess, manage and own change controls for automated equipment and computer systems.
• Identify quality issues and support/own deviation investigations as a subject matter expert for automation equipment and systems. Own resulting CAPA (Corrective and Preventative Action) or Continuous Improvement processes and actions for area(s) of responsibility.
• Author/edit technical lifecycle documentation:
  User Requirements Specifications (URS), Design Specifications (DS), Functional Specifications (FS), Configuration Specifications (CS), Standard Operating Procedures (SOP), and technical drawings.
• Author/edit/execute/support execution of Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ).
• Author/edit department SOPs with respect to compliance, best practices, and industry standards.
• Program and configure controllers, HMIs, SCADA and historian data collectors.
• Compile and analyze data, prepare reports and make recommendations for changes and/or improvements. Own process improvement implementation and process.
• Responsible for project management of automation and controls projects. Including keeping projects within budget and on schedule.
• Provide after-hours, on-call (as part of a rotation schedule), and weekend support for manufacturing when in operation or during plant shutdown activities, as needed.
• Continuously seek opportunities to innovate and enhance processes within assigned areas of responsibility.
• Maintain a safe work environment and follow site policies and procedures.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Perform any other related duties as assigned.

Knowledge, Skills & Abilities

• Advanced proficiency in Microsoft Office suite (Word, Excel, Outlook, PowerPoint, and Teams).
• Skilled in the use of various drafting/prototyping software (i.e. Auto Cad, Solidworks, Google Sketch-up, etc.).
• Proficient in programming languages in Visual Basic or C++.
• Experienced with PLC logic (ladder logic, structured text, or function block diagrams), Equipment Integration, and Automation concepts.
• Experienced with PLCs, HMIs, Data management and SCADAs to support systems. (Experience in Allen Bradley PLCs and HMIs, iFix, Wonderware, and SQL Server is preferred).
• Working knowledge with one or more of the following:
• Building Management Systems (Experience in JCI Metasys is preferred).
• Environmental Monitoring Systems (Experience with PMS Facility Pro and MODA-EM is preferred).
• Experienced with current Good Manufacturing Practices (GMP) and ISO 9001 requirements.
• Familiarity with FDA, OSHA, EPA, and other applicable regulatory and safety compliance guidelines pertaining to pharmaceutical manufacturing.
• Excellent interpersonal and communications skills both verbal and written.
• Excellent Technical writing and documentation review skills.
• Ability to read and modify equipment and electrical drawings.
• Ability to recognize deviation from accepted practice or acceptance criteria.
• Ability to handle multiple complex projects simultaneously.
• Ability to work independently or collaboratively in a fast-paced environment on multiple priorities.

Core Values

The Automation Engineer II is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to…