CQV Engineer III

PM Group • Conshohocken, PA

6h

About The Position

PM Group is seeking a CQV Engineer III to join its growing Outsourced Technical Services team in Indiana. This mid-level role combines client interaction with technical work in commissioning, qualification, and validation (CQV). The engineer handles multiple complex projects, develops documents, executes testing, and supports qualification work from design through completion. The role is mentored by senior CQV team members, provides guidance to less experienced staff, and reports to the Director of CQV. Travel to client sites is required.

PM Group is an employee-owned international project delivery firm with more than 4,000 people and over 50 years of industry experience. It serves the pharmaceutical, food, biotech, medical technology, and mission-critical sectors. The company emphasizes collaboration, inclusion, sustainability, and long-term relationships with clients and trade partners.

Requirements

• Bachelor’s degree required; an engineering degree is preferred.
• 5–10 years of CQV experience in the pharmaceutical, life sciences, biotech, and/or cell and gene therapy industries.
• Factory acceptance testing (FAT) and site acceptance testing (SAT) experience.
• Experience developing commissioning pre-functional checklists (PFCs) and performing commissioning functional performance testing (FPT).
• Experience working with current good engineering practices and current good manufacturing practices.
• Ability to understand client needs and assist with developing user requirements specifications (URS) and system impact analyses (SIA).
• Demonstrated experience working in a regulated life sciences environment.
• Experience participating actively in the document approval process.
• Understanding of the full validation life cycle and change control process.
• Experience reviewing vendor-supplied documents, such as submittal sheets and turnover packages (TOPs).
• Familiarity with the basics of design drawings.
• Full understanding of CQV testing procedures.
• Ability to document and execute cleaning validation procedures.
• Knowledge of cGMP manufacturing environments.
• Strong technical report-writing skills.
• Ability and willingness to travel as needed for client development and project execution.

Nice To Haves

• An engineering degree is preferred.

Responsibilities

• Perform work in compliance with PM Group’s Service Delivery Platforms and Quality Management System (QMS).
• Interact independently with clients to assess and continuously reassess their needs.
• Perform quality gap analyses.
• Author technical and scientific reports.
• Understand assigned project scope and the commercial aspects of the work, including hours and capital cost.
• Deliver assigned scope of work within budgeted hours.
• Develop documents and execute testing to meet client qualification needs.
• Apply the principles of good documentation practices (CGDP).
• Collaborate in a multidisciplinary team environment.
• Perform qualification protocols and review qualification documents prepared by other team members.
• Ensure implementation of current good manufacturing practices (CGMP).
• Independently assess qualification needs for equipment, facilities, utilities, and systems.
• Provide technical guidance to less experienced CQV team members.
• Complete special projects as assigned.

What This Job Offers

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