LSC have a great contract opportunity for Process Validation Engineer to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
If you have a minimum of 6-8 years' experience in the biopharmaceutical or pharmaceutical industry and are ready for your next challenge
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Develop and support the implementation of scientifically sound, fit for purpose standards and procedures for process validation and other technical procedures based on current regulations, industry standards and industry practices.
- Support the implementation of innovative and efficient approaches to validation and technical transfer by internal and external sites incorporating science and risk-based approach.
- Support the development and implementation of process validation plans and other validation documentation in collaboration with the validation and technical SME network.
- Build strong cross functional working relationships with stakeholders (Quality, Development, Technical Services and CMOs) to ensure high quality deliverables meeting cGMP and validation requirements.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A minimum of 6 years' direct experience in cGMP Process validation / technical transfer activities.
- Extensive knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
- Excellent technical writing skills
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!
Apply via this advert or contact Sarah Ninan at LSC on 021-4777329 if you have any more questions about this role!