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 |