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On-Board Companies

CQV Engineer

On-Board Companies, Conshohocken, PA, United States

On-Board Services is hiring a CQV Engineer in Conshohocken, PA!

About Us:

On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:

Position Type: Full Time / Contract (12+ months)

Job Location: Based in Conshohocken, PA (travel required)

Benefits: Health Insurance (Medical, Dental, Vision), Life Insurance, 401(k)

Compensation: $90 - $125/hr, depending on qualifications

In order to be considered for this role, you must be authorized to legally work in the US on a permanent basise without sponsorship

Overview/Summary:

 As a Commissioning, Qualification, and Validation (CQV) Start-Up/Commissioning Project Manager, you’ll join our Client's collaborative team providing Commissioning and Start-Up services to clients in the Life Sciences Industry. The position provides an excellent opportunity to work for a Global Engineering Firm and support clients that manufacture life changing products. This position is client facing with an emphasis on ensuring Commissioning project deliverables meet schedule, cost, scope, quality, and safety. This position shall be responsible for the development of start-up and commissioning plans, commissioning documentation, and execution of these documents for a variety of facilities, utility systems, and equipment. This role serves a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers. We are looking for a passionate CQV Commissioning Project Manager who is driven by collaboration, exceeding expectations, and challenging the status quo. You’ll be accountable for oversight, coordination, and execution of the start-up, energization, commissioning, and visual inspection of facilities, black and clean utility systems, HVAC, and production equipment.

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
Required Qualifications:
  • 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

Apply Today!


On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board 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.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s 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.”

On-Board Companies provides 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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