CQV Engineer II

PM Group•Rahway, NJ

About The Position

PM Group is hiring an early-career CQV Engineer II for its Outsourced Technical Services team in Rahway, New Jersey. The role supports clients throughout the project life cycle and requires both technical CQV knowledge and effective client interaction. The engineer will handle multiple complex projects, work collaboratively, and apply good documentation practices while delivering work to client needs and within budgeted hours. The position is mentored by senior CQV team members and reports to the Director of CQV. Project work may cover all levels of qualification, from design through completion, and periodic travel to client sites is expected. PM Group is an employee-owned international project delivery firm with more than 4,000 people, serving pharmaceutical, food, biotech, medical technology, and mission-critical sectors. Its business strategy emphasizes sustainability, people, clients, and trade partners.

Requirements

  • Bachelor’s degree; an engineering degree is preferred.
  • At least 2 years of CQV experience in the pharmaceutical, biotech, life science, and/or cell and gene therapy industries.
  • Experience working with current good engineering practices and current good manufacturing practices.
  • Demonstrated experience working in a regulated life sciences environment.
  • Understanding of the full validation life cycle and change control process.
  • Strong technical report-writing skills.
  • Ability to travel as needed for client development and project execution.
  • Ability to manage multiple complex projects while maintaining a strong work ethic and collaborative approach.
  • Understanding of technical aspects of commissioning, qualification, and validation.

Nice To Haves

  • Knowledge of cGMP manufacturing environments.
  • Engineering degree.

Responsibilities

  • Perform work in compliance with PM Group’s Service Delivery Platforms and Quality Management System (QMS).
  • Understand the assigned project scope of work and its commercial aspects, 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 current good documentation practices (CGDP).
  • Collaborate in a multidisciplinary team environment.
  • Independently perform qualification protocols and review other team members’ qualification documents.
  • Ensure implementation of current good manufacturing practices (CGMP).
  • Complete special projects as assigned.
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