Senior CQV Project Manager

4 weeks ago


Baltimore, Maryland, United States PES International Full time
About the Role

PES International is seeking a highly experienced CQV Project Manager to lead our team in delivering critical project management consultancy expertise. This is a client-facing position that requires strong technical knowledge and leadership skills.

The successful candidate will be responsible for managing the CQV work for a large biotechnology manufacturing project. This will involve overseeing the execution team, managing project details, and ensuring that CQV project deliverables meet schedule, cost, scope, quality, and safety requirements.

We are looking for a driven leader with a strong sense of urgency, comfortable in a fast-paced, high-energy environment. The ideal candidate will have extensive experience in facilities and equipment startup, utilities, troubleshooting, design review, IQ/OQ/PQs, and excellent interpersonal, written, and verbal communication skills.

Key Responsibilities

  • Manage the CQV work for a large biotechnology manufacturing project
  • Oversee the execution team and manage project details
  • Ensure CQV project deliverables meet schedule, cost, scope, quality, and safety requirements
  • Lead and manage C&Q resources, scope, budget, and schedule
  • Collaborate with cross-functional team members and communicate effectively with stakeholders

Requirements

  • 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, Kneat Power User preferred
  • 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

What We Offer

PES International offers a competitive compensation package and a dynamic work environment. We are committed to providing our employees with opportunities for growth and development.



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