CQV Project Lead

PM Group; Apex (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

Join a dynamic and employee-owned firm as a CQV Project Lead in Apex, NC! This exciting role offers the chance to work on cutting-edge projects in the pharma and biotech sectors, focusing on Cell & Gene Therapy. You will manage multiple complex projects, ensuring compliance with industry standards while collaborating closely with clients and team members. Your expertise in commissioning, qualification, and validation will be crucial as you lead project execution from design to completion. This position not only promises professional growth but also the opportunity to make a significant impact on global health outcomes.

Qualifications

• 7-10 years of CQV experience in CGMP Pharmaceutical and Life Sciences.
• Bachelor's degree required; engineering degree preferred.

Responsibilities

• Manage multiple CQV projects ensuring compliance and quality.
• Provide technical guidance and assess qualification needs.

Skills

Client Interaction

Project Management

Technical Report Writing

Team Leadership

Communication Skills

Education

Bachelor's Degree

Engineering Degree

Tools

Earned Value Management Systems

Project Management Professional (PMP)

Agile Project Management

Job description

Overview

The CQV Project Lead position is an exciting opportunity to join PM Group’s quickly growing Raleigh-Durham area team in Apex, NC. Together we will all be sharing knowledge, learning, growing, and continuing to be an integral part of supporting PM Group’s ongoing expansion in the US. Our office is executing cutting-edge projects for Cell & Gene Therapy, Biologics, and Pharma facilities – from feasibility through qualification – for both local and international clients. With our clients and partners, we will deliver projects that improve the everyday lives of people across the globe.

This is an advanced level career position and we are looking for a professional who enjoys client interaction as well as the technical aspects of the position. This position requires an understanding of the technical aspects of commissioning (Cx), qualification and validation (CQV). The ability to successfully handle multiple real-time complex projects while maintaining a strong work ethic, and drive to deliver for clients, as a collaborative colleague, is necessary for this role. Understanding and applying the principles of good documentation practices (CGDP) is essential to performing in this position. The CQV Project Manager is mentored by more senior level CQV team members, provides guidance to less experienced CQV staff, and will report to the Director of CQV. Their responsibilities will include document development as well as testing execution to meet client qualification needs. Expect project work to include all levels of qualification from design to completion. Project sizes will vary and the duties of the role require periodic travel to client sites.

PM Group is an employee-owned, international project delivery firm with a team of 3,600+ people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients, and trade partners.

Responsibilities

• Performs work in compliance with PM Group’s Service Delivery Platforms and Quality Management System (QMS)
• Safe execution of all project deliverables
• Overall responsibility for the CQV technical/commercial delivery and project execution
• Simultaneously manage multiple CQV projects, teams, cross-functional teams and technology transfer teams to successfully deliver projects within scope, schedule and budget. Coordinate the CQV activities between all disciplines
• Draft project proposals based on client RFPs identifying CQV resource needs, including equipment, staff and timelines
• Develop and maintain good Customer relationships and set up appropriate communications and reporting structures (meetings, reports etc.)
• Independently assess the qualification needs of equipment, facilities, utilities, and systems while tracking progress on all Customer complaints. Monitor project execution strategy effectiveness and implement controls to mitigate risk
• Provide technical guidance to less experienced CQV team members
• Monitor and enforce regulatory compliance with PM Group and Customer procedures
• Lead factory site acceptance testing (FAT) and site acceptance testing (SAT) activities
• Direct commissioning pre-functional checklist (PFC) development, and commissioning functional performance testing (FPT) activities
• Proactively assist in determining client needs related to the development of user requirements specifications (URS)
• Perform system impact analysis (SIA) and develop traceability matrices
• Perform facility CGMP Design Reviews
• Manage the validation change control process and lead the document review and approval process
• Ensure the implementation of current good manufacturing practices (CGMP), good engineering practices (GEP) including documentation practices (CGDP)
• Close out of projects including certification, handover, close-out review/report, project metrics, capturing 'Lessons Learned' and filing/archiving
• Special projects as assigned

Qualifications

• Bachelor’s degree is required; an engineering degree is preferred
• 7-10 Years of CQV experience in CGMP Pharmaceutical, Life Sciences, Biotech and/or Cell & Gene Therapy industries
• Thorough understanding of current good engineering practices (GEP) and CGMP
• Familiarity with earned value management systems; PMP and/or Agile Project Management certification is preferred
• Demonstrated excellent team leadership skills
• Excellent verbal communication, written communication, technical report writing, presentation skills and the ability to author technical and scientific reports
• Fluent in the review of basic design drawings
• The ability to travel as needed for client development and project execution