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Overview
The CQV Engineer III position is an exciting opportunity to join PM Group's quickly growing Philadelphia, PA area team in Conshohocken, PA. Together are 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 to 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 a mid-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. An understanding and applying the principals of good documentation practices (CGDP) is essential to performing in this position. The CQV Engineer III is mentored by more senior level CQV team members, provide 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 3,600+ 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)
• Independently interact with client to asses and continuously reassess client needs
• Perform quality GAP analysis
• Author technical and scientific reports
• Demonstrates an understanding of project scope of work assigned
• Demonstrates an understanding of commercial aspects (hours and capital cost) of their work
• Delivers scope of work within budgeted hours
• Document development as well as testing execution to meet client qualification needs
• Applying the principals of good documentation practices (CGDP)
• Collaborate in a multi discipline team environment
• Perform qualification protocols and review other team members qualification documents
• Ensure the implementation of current good manufacturing practices (CGMP)
• Independently assess the qualification needs of equipment, facilities, utilities and systems
• Provide technical guidance to less experience CQV team members
• Special projects as assigned

Qualifications

• Bachelor's degree is required; an engineering degree is preferred
• 5-10 Years of CQV experience in the Pharmaceutical, Life Sciences, Biotech and/or Cell & Gene Therapy industries
• Factory site acceptance testing (FAT) and site acceptance testing (SAT) experience
• Proven experience with commissioning pre-functional checklist (PFC) development and commissioning functional performance testing (FPT)
• Experience working with current good engineering and current good manufacturing practices
• Understand client needs and provide assistance with the development of user requirements specifications (URS) and system impact analysis (SIA)
• Demonstrated experience working in an industry regulated life sciences environment
• Actively participant in the document approval process
• Understanding of the entire validation life cycle and change control process
• Experience reviewing vendor supplied documents such as submittal sheets and turn over packages (TOPs)
• Familiar with and understand the basics of design drawings
• Full understanding of all commissioning, qualification and validation (CQV) testing procedures
• Ability to document and execute cleaning validation procedures
• Knowledge of cGMP Manufacturing environments is required
• Good technical reporting writing skills are mandatory
• 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 Corporate Responsibility and Heath, Safety & Well-being Report 2022.
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.
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