CQV Lead Engineer

Overview

CQV Lead Engineer - Germany, Leipzig - 3 Months Initial Contract. This innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable products, offering solutions tailored to meet the needs of both clinical and commercial markets. With a strong focus on cutting-edge technologies, they are actively driving advancements in drug substance manufacturing. Notably, their current project in Germany is centred around implementing single-use technology, which enhances efficiency and flexibility in the production process.

Responsibilities

• Define and own the CQV strategy for the project
• Develop and manage IQ/OQ protocols for equipment, utilities, and cleanroom areas
• Review and finalise protocol drafts received from vendors and internal teams
• Ensure all documentation is written in English
• Lead execution of qualification protocols
• Recommend and manage field-based CQV engineers for protocol execution if needed
• Oversee qualification activities for: Equipment, Facilities, Utilities, Cleanroom environments

Requirements

• Proven experience leading CQV activities in a Drug Substance manufacturing environment
• Strong background in utility system qualification and cleanroom re-qualification
• Skilled in writing and executing streamlined qualification protocols
• Ability to manage multiple validation streams and coordinate with field engineers
• Familiarity with single-use systems and their qualification requirements
• German language skills are a plus
• Support single-use technology implementation and validation

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Engineering and Information Technology

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