|Job Ref:||204735672||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Contract||Country:||United Kingdom||County/State:||-||City:||Ireland||Address:||Post Code:||SG17||Post Date:||05/10/2016 03:45|
Alex Tosney is recruiting for two Technical Transfer Specialists to join a pharmaceutical company based near Dublin, Ireland. This company manufacture a wide range of pharmaceutical products for the human health market and this is a fantastic opportunity to join them on a 12 month contract. |
As a Technical Transfer Specialist, the main purpose of your role will be to function as a key member of a commercial drug product technology transfer team.
Further responsibilities of this Technical Transfer Specialist will be:
• Acting as a key team member in the transfer of manufacturing site for a parental product throughout the tech transfer lifecycle from planning, development testing, and process performance qualification through to regulatory submission.
• Reviewing and writing tech transfer protocols and assessments, support manufacturing execution of test and qualification runs.
• For their assigned product(s) the product transfer engineer will support all aspects of the manufacturing process from end-to-end, from raw material release through formulation and filling to inspection, testing and release.
As a Technical Transfer Specialist, you will have the following qualifications, skills and experience:
• B.S. degree in Chemical/Biochemical Engineering, Life Sciences, or Pharmaceutical Sciences
• Demonstrable post-graduate experience in cGMP manufacturing in a biologics / pharmaceutical / medical device setting
• Solid working knowledge of cGMP's, GDP, GLP etc.
• Experience with aseptic fill finish technology platforms such as formulation, sterilisation, lyophilisation, isolators, filling machines, e-beam decontamination, automated and manual visual inspection is a strong plus.
• Experience with technology transfer is a strong plus.
• Understanding of the key quality attributes and influencers of physical and chemical stability of biologics based drug products and associated microbial, biochemical and biophysical analytical methods is a strong plus.
CK Engineers is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ENG37175 in all correspondence