CQV Engineer

2 weeks ago

Conshohocken, Pennsylvania, United States On-Board Companies Full time
About the Role

We are seeking a highly skilled Commissioning, Qualification, and Validation (CQV) Start-Up/Commissioning Project Manager to join our team at On-Board Companies. As a key member of our Client's collaborative team, you will provide 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+ years of Start-Up and Commissioning experience in the life sciences industry. Black utilities and HVAC start-up experience required
  • 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 On-Board Companies

On-Board Companies is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America. Our Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."

We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

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