Job Description:
A Tech Transfer Validation Specialist is required to support the development and implementation of scientifically sound validation and tech transfer guidance.
Responsibilities:
* Support the development of fit-for-purpose validation and tech transfer guidance based on current regulations, industry standards, and practices.
* Drive innovative and efficient approaches to validation and tech transfer incorporating science and risk-based methods.
* Collaborate with the Technical Operation team to improve validation and tech transfer practices across the network using a lean and standardized approach.
* Develop process tools including templates, tracking tools, and knowledge management systems.
* Work closely with the TO Validation and TT team on implementing business improvements.
Qualifications & Experience:
A minimum of a Bachelor's degree in a scientific discipline (Biology, Biochemistry, Biotechnology, Chemistry) or related field.
A minimum of 7 years progressive experience in the biopharmaceutical or pharmaceutical industry (Product Development, MSAT, Technical Services or Quality).
Experience in developing and using Smart Sheet as a tracking solution is an advantage.
Experience in Kneat Digital validation solutions is an advantage.
Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations.