We are seeking a highly skilled Process Validation Engineer to support our company in its mission to drive innovation. The successful candidate will be responsible for developing and implementing scientifically sound validation and testing guidance, as well as driving innovative approaches to validation and testing.
Key responsibilities include:
* Supporting the development of validation and testing processes that meet current regulations, industry standards, and practices;
* Driving efficient and science-based approaches to validation and testing;
* Supporting the ATO team to improve validation and testing practices across the network using a lean and standardized approach;
* Developing validation and testing process tools, including templates, tracking tools, and knowledge management systems;
* Collaborating with other members of the ATO validation and testing team on business improvements.
The ideal candidate will have a minimum of 7 years' experience in the biopharmaceutical or pharmaceutical industry, with expertise in bulk drug substance manufacturing and aseptic fill finish. They should also have extensive knowledge of regulations and industry practices, as well as experience working in a global and matrix environment.
A strong track record of cross-functional collaboration and experience with Smart Sheet and Kneat Digital validation solutions is an advantage. If you are a motivated and experienced professional looking to make a meaningful contribution, please apply now.