Validation Lead - North Rhine-Westphalia, Norway - 6-12 Months ContractThis 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:
- This hire will be responsible for managing the entire validation element of this project.
- Validation of:
- Equipment
- Facilities
- Utilities
- Clean room
Requirements:
- Ideally German speaking. English speaking is a prerequisite.
- Experience of owning the validation element of a project, defining the strategy, and writing the Validation Master Plan (VMP)
- Experience of writing validation protocols (currently none are written, and they anticipate needing 10-12 for the equipment).
- Experience of writing streamlined validation protocols.
- Experience of executing the protocols.
- Technical experience: Drug Substance – downstream processing; conjugation, purification, molecular, bacterial, peptides. Previously supporting validation activities in this manufacturing environment is essential.
- The ability to communicate to suppliers and internally is essential.
- Ideal experience: Single use technology.
If this role is of interest to you, please apply now! #LI-PH1