Process Validation & Technical Standards Specialist

2021-09-03 13:15:442049-01-17Team Horizon
Job TypeContractor
AreaDublinDublinIreland
SectorEngineeringQualityOperations & Manufacturing
Start Date
AdvertiserAshling Guthrie
Job Ref#2167
Job Views202
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
 
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