Controls Systems Engineer III

Johnson Controls, Inc. seeks a Controls Systems Engineer III at its facility located in Indianapolis. The role involves authoring necessary project documents, ensuring compliance with regulatory requirements, and providing consultative services while coordinating project execution plans.

Responsibilities:

• Author project documents as needed to satisfy project requirements
• Author test procedures, and summary reports to satisfy project scope requirements
• Author customer Standard Operating Procedures (SOPs) to satisfy project requirements
• Obtain protocol approval from customer representatives and route (expedites as needed) documents for signature as required
• Perform validation document peer reviews prior to customer submittal to ensure technical accuracy and compliance with customer requirements
• Interpret applicable regulatory requirements and ensure that project deliverables meet these and specific customer requirements
• Provide consultative services to internal and external customers
• Develop project execution plans and ensure plans are executed
• Coordinate with project leads to ensure CGMP requirements are met as well as ensure project schedules and cost estimates are maintained
• Assist the project lead in resolving project delays, changes and contractor disruptions
• Attend customer meetings as required to gain knowledge of project requirements and scope
• Utilize Johnson Controls standard tools for development work whenever possible
• Execute scope discovery tools such as val. scope checklist and BMS platform questionnaire, when requested
• Mentor technical writers and validation engineers as required

Requirements:

• Bachelor's degree or foreign equivalent in Industrial Engineering, Mechanical Engineering, or a related field
• Five (5) years of experience as a Validation Engineer, Quality Engineer, or related occupation involving FDA regulated industries, specifically involving pharmaceuticals
• Employment experience with commissioning, qualification, and validation of HVAC equipment
• Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, and Computer Software Assurance (CSA)
• Experience writing 15901 construction specifications, specifically HVAC controls sequences of operations
• Utilizing KneatGX to create and execute validation documentation
• Creating Functional Design Specifications and System Parameter Specifications for BMS controls systems