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Process Validation Engineer

1 month ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

Process Validation Engineer - Dublin, Ireland - 12-Month Contract Initially

Are you looking for the chance to join a life-changing pharmaceutical organization in their mission to continuously drive innovation? We are recruiting for a Process Validation Engineer to support the company.

Process Validation Engineer Responsibilities:

1. Support the development and implementation of scientifically sound, fit for purpose Validation and TT guidance based on current regulations, industry standards, and industry practices.
2. Drive innovative and efficient approaches to Validation and TT incorporating science and a risk-based approach.
3. Support the ATO 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.
4. 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.
5. Work closely with other members of the ATO Validation and TT team on the implementation of business improvements.

Requirements as a Process Validation Engineer:

1. A minimum of 7 years’ progressive experience in the biopharmaceutical or pharmaceutical industry (Product Development, MSAT, Technical Services, or Quality).
2. Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
3. Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations.
4. Strong track record of working in a global and matrix environment, working cross-functionally.
5. Experience in developing and using Smart Sheet as a tracking solution is an advantage.
6. Experience in Kneat Digital validation solutions is an advantage.

If this role is of interest to you, please apply now

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