Technical Services Specialist


Category: Manufacturing, Pharmaceutical / Science
Job Type: Full Time

Posted on:
Last Updated:

The role:

PE Global is currently recruiting for a Technical Services Specialist on behalf of our client based in Athlone. This is an initial 12-month contract role.

Responsibilities:

  • Provide significant technical expertise to support all aspects of the mammalian bulk drug substance cell culture and purification manufacturing.
  • Process SME to support commissioning, automation and manufacturing operation teams.
  • Support technology transfers of new products into the facility
  • Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables.
  • To author and review process supporting documentation, process descriptions, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
  • To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting.
  • Partner with Operations to support protocol completion, execution and sample reconciliation.
  • To generate documentation reports for technical studies
  • Lead any key process changes using change control management system as required.
  • Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.

Education and Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
  • Experience in technical services support in the manufacture of mammalian drug substance cell culture and purification and/or process development and/or manufacturing support
  • Experienced in relevant unit operations including vial thaw and scale up, seed train and production bioreactors, harvest, chromatography, UF/DF, viral filtration and inactivation, final formulation and media and buffer preparations.
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically in the manufacture of mammalian bulk drug substance operations.
  • Prior experience of single use systems (bioreactors, single use mixers) would be an advantage

PE Global


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