Context:

Inova Consulting (Lausanne, Switzerland) is a specialized engineering and life-science consulting firm supporting the biotech and pharmaceutical industry. We deliver high-value expertise in process development, GMP compliance, qualification & validation, and digital transformation to help clients optimize operations and ensure regulatory readiness.

Biotech manufacturing site (client environment)

Role & Responsibilities:

• Take full ownership of USP equipment requalification activities following equipment modifications
• Define the overall qualification and validation strategy
• Prepare qualification protocols and test definitions (IQ/OQ/PQ as applicable)
• Execute qualification activities in collaboration with Manufacturing and Engineering teams
• Manage and investigate deviations, propose and implement corrective actions
• Ensure compliance with GMP, site procedures, and regulatory requirements
• Support change control and validation documentation lifecycle

Required Experience & Skills:

• Proven experience with USP equipment qualification
• Strong knowledge of buffer and media tanks, CIP/SIP systems, and stainless steel process equipment
• Experience in qualification of automation systems
• Solid background in validation strategy preparation and test definition
• Ability to work autonomously in a regulated GMP environment