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Project Manager

Thousand Oaks, CA · Healthcare
Top 3 Must Have Skill Sets:    
  • Good Fundamental Leadership and Values
  • Good Fundamental Engineering
  • Good Fundamental Project Management
  • Looking for a PM who will support manufacturing plant/ engineering group.
Day to Day Responsibilities:    
  • Be individually accountable for the verification deliverables on key capital projects
  • Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
  • Assist in development and review of User Requirements Specifications (URS).
  • Suggest design modifications to address risks and design in quality and safety.
  • Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).
  • Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.
  • Recommend, evaluate, and manage performance of contract resources
  • Provide oversight for verification deliverables developed by outsourced/contract verification staff.
  • Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout
  • Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
  • Ensure safety during commissioning, validation, maintenance, and manufacturing activities
  • Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed
  • Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable
  • Suggest design modifications to address risks and design in quality and safety
  • Develop commission strategy
  • Oversee development of validation protocols, Automation System Delivery
  • Lead teams
Red Flags:        
  • Poor Leadership: Safety & Quality
  • Poor Communication
  • Poor Teamwork
PAY RATE : $65-$74 /hr on W2

"This posting is for Contingent Worker, not an FTE"

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