Job Title: Tech Transfer Validation Specialist
About the Role:
A Tech Transfer Validation Specialist is required to develop and maintain validation and Tech Transfer guidance in support of implementation. This includes ensuring that validation guidance is fit for purpose across multiple modalities, updated as new modalities are introduced to the pipeline.
Responsibilities:
* Support the development and implementation of scientifically sound, fit for purpose Validation and TT guidance based on current regulations, industry standards and practices.
* Drive innovative and efficient approaches to Validation and TT incorporating science and risk-based approach.
* Collaborate with the Technical Operation team to continuously improve Validation and TT practice across the network using a lean and standardized approach.
* Develop Validation and TT process tools, including TT templates, tracking tools, knowledge management tools, and digital solutions to support driving necessary TT Process improvements.
Qualifications & Experience:
A minimum Bachelors degree in a scientific discipline or related field is required. A minimum of 7 years progressive experience in the biopharmaceutical or pharmaceutical industry is also required.
* Experience in developing and using Smart Sheet as a tracking solution is an advantage.
* Experience in Kneat Digital validation solutions is an advantage.
* Experience in Bulk Drug Substance manufacturing and aseptic fill finish is desirable.
Skills:
* MSAT Technical Services
* Kneat Digital validation solutions
* Bulk Drug Substance
* Smart Sheet