Engineering , Science, Pharmaceutical & Food

Technical Services Specialist – Upstream

  • Contract
  • Remote
  • Dublin West
  • 41957223

PE Global is currently recruiting for a Technical Services Specialist (Upstream) for a leading multi-national Biotecha client based in Dublin West.

This is an initial 12-month contract position.

 

ROLE:

  • To provide process expertise in Upstream unit operations to include media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification)
  • To author and review process documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents
  • To identify requirements for laboratory studies to support process decisions or process transfer, and to liaise closely with Process Development / MSAT to oversee the design and execution of studies
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements
  • 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
  • To identify and implement process improvements, e.g. yield, cycle time reduction
  • To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale
  • May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution and provide on-call support to manufacturing.
  • To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
  • Lead any key process changes using change control system
  • Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits
  • To author and review common technical document (CTD) sections and reports for regulatory agency submissions
  • To serve as a subject-matter expert (SME) on Upstream unit operations and process support during regulatory agency inspections

 

REQUIREMENTS:

 

  • Minimum 2+ years’ experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization
  • Technical and operational knowledge of multiple unit operations in upstream processing
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings
  • Ability to present and defend technical and scientific approaches in both written and verbal form
  • Ability to drive for results independently and adapt to rapidly changing priorities

 

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@peglobal.net 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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