Job Title: Tech Transfer Validation Specialist
A biopharmaceutical company in West Dublin is seeking a skilled professional to develop and maintain validation and tech transfer guidance.
The successful candidate will be responsible for ensuring that validation guidance is fit for purpose across multiple modalities and updated as new modalities are introduced to the pipeline.
Responsibilities:
* Develop and implement scientifically sound, fit for purpose validation and tech transfer guidance based on current regulations, industry standards, and industry practices.
* Drive innovative and efficient approaches to validation and tech transfer incorporating science and risk-based approach.
* Support the technical operation team to continuously improve validation and tech transfer practice across the network using a lean and standardized approach.
* Develop validation and tech transfer process tools, including templates, tracking tools, and knowledge management tools.
* Work closely with the technical operation, validation, and tech transfer team on implementation of business improvements.
Qualifications & Experience:
* Bachelor's degree in a scientific discipline (biology, biochemistry, biotechnology, chemistry), or related field.
* Minimum 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.