Process Validation & Technical Standards Specialist

2021-09-03 13:15:442049-01-17Team Horizon
Job TypeContractor
SectorEngineeringQualityOperations & Manufacturing
Start Date
AdvertiserAshling Guthrie
Job Ref#2167
Job Views202
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
Apply Later
Sign in
Ashling Guthrie
Browse Ashling's jobs
Get in touch with Ashling
Similar Jobs
  • Automation & Business Technology Systems Lead (Information Technology)
    Ireland, Cork

    Team Horizon currently has an exciting opening for an Automation & Business Technology Systems Lead (Information Technology) to join our client’s modern ‘bulk tablet’ finish facility which manufactures solid and capsule formulations.
    Reporting to the Engineering Manager,...
  • Environmental Validation Test Technician
    Ireland, Galway

    Team Horizon is seeking an Environmental Validation Test Technician who to join our client’s state of the art automotive vision systems manufacturing facility in the West of Ireland. In this role you will be responsible for preparing and executing the validation tests according to a validation...
  • CQV Engineer (Upstream/Downstream)
    Ireland, Dublin

    Team Horizon currently has an exciting opening for a CQV Engineer to work on Upstream, Downstream and Process Utilities. This role allows an opportunity to join a team for the execution phase on dynamic project for blue chip bio pharma client.
    What you will be doing:
Email Me Jobs Like This
Subscribed to similar jobs notifications
We use cookies to provide you with the best possible browsing experience on our website. You can find out more below.
Cookies are small text files that can be used by websites to make a user's experience more efficient. The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission. This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.
ResolutionUsed to ensure the correct version of the site is displayed to your device.
SessionUsed to track your user session on our website.
Statistic cookies help website owners to understand how visitors interact with websites by collecting and reporting information anonymously.
Google AnalyticsGoogle Analytics is an analytics tool to measure website, app, digital and offline data to gain user insights.

More Details