CQV Lead

Job Overview

We are seeking an experienced CQV Lead to lead the coordination and execution of a large laboratory equipment deployment initiative within a pharmaceutical manufacturing and research environment. The successful candidate will oversee equipment onboarding, installation, qualification, and startup activities while coordinating with vendors, subject matter experts, automation teams, and cross-functional stakeholders. This role requires strong technical knowledge combined with leadership and vendor management capabilities to ensure laboratory systems are installed, qualified, and operational according to project requirements.

Position: CQV Lead
Location: Indiana
Duration: Long Term

• Lead the coordination and execution of laboratory equipment onboarding and deployment activities.
• Coordinate equipment installation, startup, commissioning, qualification, and validation activities.
• Manage vendor resources and coordinate activities across multiple equipment providers.
• Work closely with laboratory SMEs, automation teams, engineering, validation, and other cross-functional stakeholders.
• Track project activities, deliverables, timelines, and equipment readiness.
• Facilitate communication between internal project teams and external vendors.
• Support laboratory startup, expansion, and equipment implementation programs.
• Ensure equipment activities align with project requirements and applicable pharmaceutical quality standards.
• Review and support qualification documentation and associated workflows.
• Drive issue resolution and ensure equipment is delivered and operational within project timelines.

• 5 10+ years of experience supporting CQV, commissioning, qualification, validation, or laboratory equipment implementation within pharmaceutical or highly regulated environments.
• Significant experience with analytical laboratory equipment, including equipment installation and startup activities.
• Proven experience in people leadership and vendor management, with the ability to coordinate multiple stakeholders and drive project execution.
• Strong understanding of equipment qualification, commissioning, validation, and laboratory implementation processes.
• Experience working with cross-functional teams, equipment vendors, SMEs, and technical stakeholders.
• Experience with KNEAT documentation and qualification workflows.
• Exposure to process equipment such as TFF systems, bioreactors, or related manufacturing technologies.
• Experience with GMARS or computerized maintenance/asset management systems.