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Senior Commissioning and Qualification Manager

2 months ago

Rahway, New Jersey, United States PES International Full time
Job Summary

We are seeking a highly experienced Commissioning and Qualification (CQV) Project Manager to join our team at PES International. As a CQV Project Manager, you will be responsible for managing the CQV work for a large biotechnology manufacturing project.

Key Responsibilities
  • Manage CQV project deliverables to meet schedule, cost, scope, quality, and safety requirements.
  • Oversee technical details, including Kneat and the execution team, and project details for the project.
  • Lead and manage C&Q resources, scope, budget, and schedule.
  • Collaborate with cross-functional team members to ensure successful project execution.
  • Develop and implement project plans, timelines, and budgets.
  • Ensure compliance with GMP regulations and industry standards.
  • Provide technical guidance and support to project team members.
  • Identify and mitigate project risks.
  • Develop and maintain relationships with clients and 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.
  • 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.
  • Clear communicator with excellent interpersonal, written, and verbal communication skills.
  • Collaborative team player with strong leadership skills.
  • Detail-oriented with the ability to see the big picture and work effectively at both high and detailed levels.
  • Extensive experience in facilities and equipment startup, utilities, troubleshooting, design review, IQ/OQ/PQs, etc.
  • Bachelor's degree in Chemical, Biomedical, or Electrical Engineering, or relevant degree, or equivalent years of hands-on experience.
What We Offer

PES International offers a dynamic and challenging work environment with opportunities for professional growth and development.