Job description

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. AutoCad, 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 FacilityPro 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 change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes. • Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. • Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality. • Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future. Education & Experience • Bachelor’s degree in engineering, Computer Science or related field of study required. • Minimum of 3 years of equipment automation or computer system experience in a regulated industry required (pharmaceutical industry preferred). • Experience in database design, management and maintenance is preferred. Working Conditions • Laboratory, Manufacturing and Office environment. • Occasional travel between Fort Collins and Windsor manufacturing sites to support essential duties and responsibilities. • 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. Compensation and Benefits • Pay: $105,000 to $120,000, depending on experience • Benefits summary: tolmar.com Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Requirements

Must-haves

Monday - Friday, 8:00 am - 5:00 pm, on-call as needed
Purpose and Scope
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.
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.
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. AutoCad, Solidworks, Google Sketch-up, etc.).
Proficient in programming languages in Visual Basic or C++.

Nice-to-haves

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).
Building Management Systems (Experience in JCI Metasys is preferred).
Environmental Monitoring Systems (Experience with PMS FacilityPro and MODA-EM is preferred).
Minimum of 3 years of equipment automation or computer system experience in a regulated industry required (pharmaceutical industry preferred).
Experience in database design, management and maintenance is preferred.

Application prep

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