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
Numbers & Facts
Location
South San Francisco, CA
Skills
Asset Managementunmatched
Automationunmatched
Budgetingunmatched
Calibrationunmatched
Change Controlunmatched
Commissioningunmatched
Computer Systemsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Documentationunmatched
Environmental Management Systemsunmatched
GMP (Good Manufacturing Practices)unmatched
Green Constructionunmatched
Hardware Upgradesunmatched
Identify Issuesunmatched
Instrumentationunmatched
Keyboardsunmatched
Leadershipunmatched
Manual Dexterityunmatched
Operations Managementunmatched
Policy Developmentunmatched
Programmable Logic Controller (PLC)unmatched
Project/Program Managementunmatched
Property Managementunmatched
Regulatory Complianceunmatched
Requirements Managementunmatched
Riskunmatched
Sales Qualificationunmatched
Standard Operating Procedures (SOP)unmatched
System Operationsunmatched
Systems Administration/Managementunmatched
Systems Maintenanceunmatched
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