CQV Engineer III

Overview

The CQV Engineer III position is an exciting opportunity to join PM Group's quickly growing Outsourced Technical Services(OTS) team in Indiana. 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 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. Must be willing to travel to the client site.

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.

RECRUITMENT AGENCIES NEED NOT APPLY

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