CQV Engineer III

PM Group • San Diego, CA

1d • Remote

About The Position

The CQV Engineer III position is an exciting opportunity to join PM Group’s quickly growing Outsourced Technical Services(OTS) team near San Diego, CA. 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.
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
• 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

Responsibilities

• Performs work in compliance with PM Group’s Service Delivery Platforms and Quality Management System (QMS)
• Independently interact with client to assess 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

Benefits

• employee-owned company
• inclusive
• committed
• driven
• Corporate Responsibility and Sustainability are the heart of our new 2026 business strategy
• Inclusion and Diversity are core to our culture and values
• culture of mutual respect and belonging
• 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
• hiring process is fair and accessible to all
• provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process

What This Job Offers

• Job Type: Full-time
• Career Level: Senior