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CQV Project Manager

2 months ago

Rahway, United States PES International Full time
Job DescriptionJob Description

CQV Project Manager  
Pharmaceutical 

Company: PES International 
Location: Newark, NJ 
Compensation: Commensurate with Experience  
 
About this opportunity:  

PES International is an international industry leader in providing automation, commissioning, qualification, and CSV services. We have an unrivaled knowledge based in these specialist areas from initial concept design through to commissioning and qualification of your facility. We’re actively building out our US presence and looking for talented team members to work with us in delivering critical project management consultancy expertise.  

This role will be responsible for managing the CQV work for a large biotechnology manufacturing project. This is a client facing position ensuring CQV project deliverables meet schedule, cost, scope, quality and safety requirements. This position will be responsible for managing all technical details, overseeing Kneat and the execution team, and project details for the project. This is a multi-year project. 

What we’re looking for:  

  • 10+ years of experience in commissioning, qualification and validation in pharma or biotech industries  

  • 7+ years of leadership experience in managing teams related to CQV  

  • Experience working with Kneat is required 

  • Experience leading and managing C&Q resources, scope, budget, and schedule 

  • Experience with GMP facilities including commissioning, qualification, and validation of biotechnology equipment, facilities, and equipment is required.  

  • Clear communicator who can process and position problems proactively within an organization  

  • Collaborative team player who is comfortable leading as well as executing projects  

  • Driven leader with a strong sense of urgent, comfortable in a fast-pace, high-energy environment, able to meet multiple tight deadlines  

  • Detail oriented with the ability to see the big picture and to work effectively at both high and detailed levels with leadership and the CQV team 

  • Extensive experience in facilities and equipment startup, utilities, troubleshooting, design review, IQ/OQ/PQs, etc.  

  • Work and interact with cross-functional team members  

  • Excellent interpersonal,  written, and verbal communication skills 

  • Bachelor’s degree in Chemical, Biomedical, or Electrical Engineering, or relevant degree, or equivalent years of hands-on experience

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