CQV Project Lead

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 principals 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 periotic travel to client sites.

PM Group is an employee owned, international project delivery firm with a team of 3,700+ 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 (meeting, reports etc.)

Independently asses 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 experience 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 tractability 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 understand 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 of design drawings

The ability to travel as needed for client development and project execution

All of your information is confidential according to EEO guidelines.

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our 2024 Environmental, Social and Governance Report.

Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.

RECRUITMENT AGENCIES NEED NOT APPLY

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