CQV Project Manager

About the role

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Project Manager of CQV to join our team at our project site near Lexington, Kentucky.

Responsibilities

• Perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients.
• Follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements.
• Interface directly with IPS clients in the delivery of projects, including routine communications, leading project meetings, tracking, and reporting project metrics (financial and deliverables).
• Self-direct and direct the assigned project team, maintain positive client relationships, etc.
• Manage and perform standalone commissioning services for non-FDA-regulated clients.

Qualifications & Requirements

• Bachelor’s degree in Engineering, Project Delivery, or a related discipline, or an equivalent technical degree.
• 7+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
• Experience with Risk-Based Approach to Commissioning and Qualification.
• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
• Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes.
• Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
• Project Management Professional (PMP) certification or Professional Engineer (PE) license.