Overview The
CQV Engineer II position is an exciting opportunity to join PM Group's quickly growing Outsourced Technical Services(OTS) team in
Rahway, NJ. 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 early 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 II is mentored by more senior level CQV team members 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. Periodic travel to client site is expected.
Responsibilities - Performs work in compliance with PM Group's Service Delivery Platforms and Quality Management System (QMS)
- 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
- Independently perform qualification protocols and review other team members qualification documents
- Ensure the implementation of current good manufacturing practices (CGMP)
- Special projects as assigned
Qualifications - Bachelor's degree is required; an engineering degree is preferred
- 2 + Years of CQV experience in the Pharmaceutical, Biotech, Life Science and/or Cell & Gene Therapy industries
- Experience working with current good engineering and current good manufacturing practices
- Demonstrated experience working in an industry regulated life sciences environment
- Understanding of the entire validation life cycle and change control process
- Knowledge of cGMP Manufacturing environments is preferred
- Good technical reporting writing skills are mandatory
- The ability to travel as needed for client development and project execution
Pay Range Disclosure: The pay range for this position is $85,000 - $105,000 annually. This range represents the base salary that PM Group reasonably expects to pay for this role at the time of posting. The actual compensation offered will depend on factors such as work location, qualifications, skills, and relevant experience.
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