Summary: A Tech Transfer Validation Specialist is required for a biopharmaceutical company in West Dublin.
The successful candidate will be responsible for developing and maintaining validation (process and cleaning validation, continued process verification) and Tech Transfer (TT) guidance to support implementation.
This will include ensuring that validation guidance is fit for purpose across multiple modalities and updated as new modalities are introduced to the pipeline.
The incumbent will work closely with other members of the Technical Operation (TO), TT and Validation team to identify business process or tools that are critical to a successful and lean Validation and TT process.
Responsibilities: Support the development and implementation of scientifically sound, fit for purpose Validation and TT guidance based on current regulations, industry standards and industry practices.
Drive innovative and efficient approaches to Validation and TT incorporating science and risk-based approach.
Support the TO team to continuously improve Validation and TT practice across the network using a lean and standardized approach that can be replicated and continuously improved for subsequent product transfers.
Support the development of Validation and TT process tools including TT templates, tracking tools, knowledge management tools e.g.
Smart Sheet and potentially other digital solutions to support driving necessary TT Process improvements.
Work closely with other members of the TO Validation and TT team on implementation of business improvements.
Qualifications & Experience: Minimum Bachelors degree in a scientific discipline (Biology, Biochemistry, Biotechnology, Chemistry), or related field.
A minimum of 7 years progressive experience the biopharmaceutical or pharmaceutical industry (Product Development, MSAT, Technical Services or Quality).
Experience in developing and using Smart Sheet as a tracking solution an advantage.
Experience in Kneat Digital validation solutions an advantage.
Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations.
Skills: MSAT Technical Services Kneat Digital validation solutions Bulk Drug Substance Smart Sheet