CQV/Qualification Engineer

Stellenbeschreibung:

CQV/Qualification Engineer - Dortmund, Germany - 2-3 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.

What You’ll Do

Develop and execute qualification documents including URS, risk assessments, IQ/OQ protocols, reports, and supporting documentation.
Collaborate with stakeholders to ensure timely review and approval of documentation.
Report progress, manage timelines, and ensure alignment with project milestones.

What You’ll Need

Extensive experience in CQV/qualification engineering within the biopharmaceutical industry.
Proven track record qualifying equipment such as bioreactors, ultra‑filtration, chromatography, and related systems.
Strong knowledge of GMP, regulatory requirements, and risk management principles.
Fluent German speaker (mandatory).

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