CQV Project Manager

PM Group•Indianapolis, IN

20h

About The Position

The CQV Project Manager position is an exciting opportunity to join PM Group’s quickly growing Philadelphia area Outsourced Technical Services team at a client site in Indianapolis, VA. Outsourced Technical Services (OTS) is an integral part of PM Group’s ability to support clients across the complete project life cycle. We have over 50 years’ industry experience, strong technical knowledge and integrated resources. Clients look to us to provide experienced technical professionals that complement their project teams. Together we are sharing knowledge, learning, growing and continuing to be an integral part of supporting PM Group’s ongoing expansion in the US. 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 4,000+ 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.

Requirements

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
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

Nice To Haves

Familiarity with earned value management systems; PMP and or Agile Project Management certification is preferred

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