Senior CQV Start-Up/Commissioning Project Manager LSNA

3 weeks ago


Conshohocken, Pennsylvania, United States Jacobs Full time

Commissioning and Qualification Project Manager Role

We are seeking a highly skilled Commissioning and Qualification Project Manager to join our team at Jacobs. As a Commissioning and Qualification Project Manager, you will be responsible for providing Commissioning and Start-Up services to clients in the Life Sciences Industry.

Key Responsibilities

  • Develop Project Start-Up and Commissioning Plans 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

Requirements

  • 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

Preferred Qualifications

  • Proposal development experience
  • Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
  • Knowledge of industry guidance: ISPE Baseline Guide 5 Commissioning and Qualification, ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems, ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, ISPE Guideline: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment, 2011, ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, 2011
  • Six Sigma Certification

About Jacobs

Jacobs is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law.



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