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Biopharmaceutical Validation Specialist

2 weeks ago

Tullamore, Uíbh Fhailí, Ireland Quanta Consultancy Services Ltd Full time
About the Role: As a Process Validation Engineer at Quanta Consultancy Services Ltd, you will play a critical role in ensuring the quality and safety of pharmaceutical products. Your primary responsibilities will include supporting the development and implementation of scientifically sound validation and testing guidance, as well as driving innovative approaches to validation and testing.

Main Responsibilities:

- Develop and implement scientifically sound, fit for purpose validation and testing guidance based on current regulations, industry standards, and industry practices.
- Collaborate with cross-functional teams to drive innovative and efficient approaches to validation and testing incorporating science and a risk-based approach.
- Support the development of validation and testing process tools including templates, tracking tools, knowledge management tools, and potentially other digital solutions to support driving necessary process improvements.

Requirements:

- A minimum of 7 years' progressive experience in the biopharmaceutical or pharmaceutical industry (Product Development, MSAT, Technical Services, or Quality).
- Experience of biopharmaceutical bulk drug substance 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 is an advantage.
- Experience in Kneat Digital validation solutions is an advantage.