Process Validation & Technical Standards Specialist
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Job Type | Contractor |
Area | Dublin |
Sector | EngineeringQualityOperations & Manufacturing |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | #2167 |
Job Views | 249 |
- Description
- We have an exciting opportunity for our client, who are a leading biopharmaceutical company based in Dublin.If successful you will be part of a dynamic team developing standards and guidelines across the internal and external manufacturing network.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
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.
Deliver associated training to colleagues.
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 company validation requirements.
What you need to apply:
Minimum Bachelors’ degree in a scientific discipline (Biology, Biochemistry, Biotechnology, Chemistry), or related field.
A minimum of 6-8 years’ experience in the biopharmaceutical or pharmaceutical industry (Validation, Technical Services or Quality).
A minimum of 6 years’ direct experience in cGMP validation activities.
Widespread knowledge of Validation regulations, current validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
Outstanding technical writing skills
Knowledge of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
Proven active participation in industry and regulatory forums shaping validation practices and strategy.
Strong track record of working in a global and matrix environment and working cross functionally