Validation Specialist

Desired Skills: validation,API,aseptic,drug substance

The role:

PE Global is currently recruiting for a Validation & Tech Transfer Specialist on behalf of a leading pharmaceutical company based in Dublin. This is an initial 12 month contract role.

Description:

• 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 pipeline.

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.

Education and Experience:

• Minimum Bachelors’ degree in a scientific discipline (Biology, Biochemistry, Biotechnology, Chemistry), or related field.
• A minimum of 5 years’ progressive experience the biopharmaceutical or pharmaceutical industry (Product Development, MSAT, Technical Services or Quality).
• Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
• Experience of small molecule API manufacturing and oral solid dose preferred.
• Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations.
• Strong track record of leading in a global and matrix environment, working cross functionally and developing strong technical talent.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***