You will also be responsible for the following duties:
• Develop Project Start-Up and Commissioning Plan and execution strategies
• Lead the team in Developing System Start-Up and Commissioning Plans for black utility and HVAC systems
• Lead the team in Generating and executing Start-Up and Commissioning documents according to Good Documentation Practices (GDPs)
• Startup equipment in a safe and effective manner
• Facilitate meetings for the start-up Team
• Maintain action item lists
• Maintain engineering change control logs
• Provide technical assistance and input
• Coordination of OEM Service technicians as needed
• Coordination with construction management firm as needed
• Apply engineering knowledge of, and experience with, HVAC, black utilities, instrumentation, controls, and automation to support clients
• BS in Mechanical, Electrical or Chemical Engineering or equivalent years of experience in lieu of degree
• 5-14 years of Start-Up and Commissioning experience in the life sciences industry
• Understanding of Good Manufacturing Practices (GMPs)
• Understanding of Good Documentation Practices (GDPs)
• Proficient with Microsoft Office – Word, Excel
• Flexibility and willingness to travel and work at various clients’ locations
• Ability to work well with diverse, multi-disciplined groups
• Ability to effectively communicate with management and fellow project team members
• Ability to negotiate/compromise with other project team members to achieve project goals
• Ability to listen and respect fellow project team member’s ideas and opinions and work through conflicts or disagreements
Ideally, you’ll also have:
• Proposal development experience
• Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
• Knowledge of industry guidance:
o ISPE Baseline Guide 5 Commissioning and Qualification
o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
o ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
o ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011
o ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
• Six Sigma Certification
