Serve as Subject Matter Expert (SME) for the environmental and building management systems and PLCs
• Create and review system lifecycle documents including commissioning and qualification, SOPs, drawings, TOPs and change control.
• Ensure effective operation of systems by monitoring, troubleshooting, and maintaining systems in a reliable, compliant state as evidenced by measurements
• Lead the implementation of automation solutions based on your previous cGMP experience
• Support and or lead instrumentation specification, troubleshooting, and lifecycle management
• Lead and/or support multiple small to large sized projects of significant complexity and risk as required
• Provides leadership and direction to engineers and contractors
• Support and/or lead building and initiating engineering policies
• Support the creation of SOP's and other compliance related documentation as appropriate
• Support/lead commissioning and qualification requirements and documentation
• Support/lead compliance requirements such as change control, deviations and CAPA's
• Support the asset management program
• Other duties as assigned
Skills:
• Frequent use of a computer monitor, keyboard and mouse required
• Frequent lifting, carrying, pushing, or pulling up to 20 pounds required
• Frequent periods of sitting, walking, and standing required
• Frequent use of personal protective equipment required
• Occasional climbing stairs or ladders, bending or stooping, crouching, or squatting required
• Occasional fine finger dexterity/ including grasping or pinching required
• Occasional work in cold rooms and freezers required
Education:
• Bachelor's degree in Engineering or Science discipline
• 8+ years of relevant industry experience and practical experience with Client (Siemens Desigo CC is strongly preferred) and PLCs including administration, programming, data handling, and interfaces
• Working knowledge of instrumentation and calibration, GMP, change control and validation related to control and computer systems.
• Demonstrated ability to develop requirements, scope, budget, timelines and manage automation projects including new and upgrades to automated computer systems
