Expoint - all jobs in one place

המקום בו המומחים והחברות הטובות ביותר נפגשים

Limitless High-tech career opportunities - Expoint

Jacobs Senior CQV Start-Up/Commissioning Project Manager Life Sciences 
United States, Pennsylvania 
809104741

17.08.2024
Your impact

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

Here's what you'll need

• 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