Validation & Tech Transfer Specialist
| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | EngineeringQualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3465 |
| Job Views | 70 |
- Description
Team Horizon is seeking a Validation Specialist with experience supporting Tech Transfers for a Dublin based Biopharmaceutical company.
Why you should apply:
- Opportunity to join a high performong team developing procedures and support Business Process Improvements
- Hybrid Role, 3 days on site
What you will be doing:
- 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 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.
- 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 ATO Validation and TT team on implementation of business improvements
What you need to apply:
- A minimum of 7 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.
- Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations.
- Strong track record of working in a global and matrix environment, working cross functionally.
- Experience in developing and using Smart Sheet as a tracking solution an advantage.
- Experience in Kneat Digital validation solutions an advantage.
- Education Minimum Bachelors’ degree in a scientific discipline (Biology, Biochemistry, Biotechnology, Chemistry), or related field.
