Process Validation Engineer
We are recruiting for a Process Validation Engineer to support our mission to continuously drive innovation in the pharmaceutical industry.
This is a 12-month contract initially, and we are looking for someone with a minimum of 7 years' progressive experience in the biopharmaceutical or pharmaceutical industry.
* Support the development and implementation of scientifically sound validation and testing guidance based on current regulations, industry standards, and practices.
* Drive innovative approaches to validation and testing incorporating science and risk-based methodologies.
* Support the ATO team in improving validation and testing practice across the network using a lean and standardized approach.
* Develop validation and testing process tools, including templates, tracking tools, and knowledge management systems.
* Work closely with the ATO validation and testing team on business improvements.
Requirements
* Minimum 7 years' experience in product development, MSAT, technical services, or quality in the biopharmaceutical or pharmaceutical industry.
* Experience in biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
* Extensive knowledge of regulations and industry practices, with experience interpreting and applying guidelines and regulations.
* Strong track record of working in global and matrix environments, working cross-functionally.
* Experience developing and using Smart Sheet as a tracking solution is an advantage.
* Experience with Kneat Digital validation solutions is an advantage.