The Validation & Tech Transfer Specialist will be responsible for developing and maintaining validation (process and cleaning validation, continued process verification) and tech transfer guidance and supporting toolkit to support implementation in a consistent manner across products and sites. This will include ensuring that validation standards and procedures are fit for purpose across multiple modalities and are updated as new modalities are introduced to the site pipeline based in Dublin.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Lead, 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 implementation of TT and Validation best practices across the network, work closely with other members of the ATO TT and Validation team on implementation of improvements.
- A minimum of 5 years' progressive experience the biopharmaceutical or pharmaceutical industry (Product Development, MSAT, Technical Services or Quality).
- Experience of small molecule API manufacturing and oral solid dose preferred.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A minimum of 5 years' progressive experience the biopharmaceutical or pharmaceutical industry (Product Development, MSAT, Technical Services or Quality).
- Minimum Bachelors' degree in a scientific discipline (Biology, Biochemistry, Biotechnology, Chemistry), or related field.
- Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Sarah Ninan at LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert.
