CQV Lead Engineer

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 manageIQ/OQ protocolsfor equipment, utilities, and cleanroom areas
• Review and finalise protocol drafts received from vendors and internal teams
• Ensure all documentation is written inEnglish
• 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 aDrug Substancemanufacturing environment
• Strong background inutility system qualificationandcleanroom re-qualification
• Skilled in writing and executingstreamlined qualification protocols
• Ability to manage multiple validation streams and coordinate with field engineers
• Familiarity withsingle-use systemsand their qualification requirements
• German language skills are a plus
• Support single-use technology implementation and validation.

If this role is of interest to you, please apply now!
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