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Specialist Technical Services, Dublin



Dublin, Ireland 

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Job Description:

The Opportunity

Team Horizon have an opportunity for a Specialist Technical Services. The Process Validation Specialist has primary responsibility in supporting the successful start-up and process validation (PPQ) of cGMP manufactured biological bulk drug substances (BDS) as part of the Technical Services Team at the company’s facility in Blanchardstown, Dublin.

The Process Validation Specialist will support all process validation (PPQ) activities, with particular focus on prospective Process validation (PPQ) and associated supporting concurrent validation protocol, and process monitoring programs in support of OPV/CPV.

The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility start-up and process qualification (PPQ).

The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, delivery of Process Validation (PPQ), Process Monitoring, Risk Assessments (using QRM tools), and building strategies / SME capability.

The Role

  • To provide process expertise in the area of process validation, including process performance qualification (PPQ) and continued process verification (CPV)
  • Working knowledge of typical drug substance unit operations, including upstream cell expansions and bioreactors, harvest operations and downstream chromatography and filtration unit operations and functional purpose, cause and effect, in-process tests, and mass balance principles
  • To author and review process validation documentation (protocols/reports), including validation strategies, risk assessments, protocols and reports, including process validation documentation & strategy documents
  • 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
  • May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution as required
  • To provide on the floor support for troubleshooting processing issues and to lead technical assessment of investigations into process deviations and resolution with CAPAs
  • Lead any key process changes using change control management 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
  • Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits and incident investigations
  • To author and review and assist in documents that input into IND, BLA and other technical documents for regulatory agency submissions

The Person

  • Minimum requirement of B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering (5+ years’ experience), or PhD (3 years’ experience)
  • Minimum 5+ years’ experience in Technical Services / Process Development / Manufacturing Support / Research with experience in leading process validation projects (PPQ) in a biological bulk drug substance or equivalent manufacturing processes
  • Experience in developing validation strategies, as well as writing validation protocols and reports, (with multi product focus)
  • Technical and operational knowledge of multiple unit operations in typical BDS unit operations
  • 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
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing, including process validation, OPV/CPV
  • Technical writing competency
  • Detail orientated
  • Experience of Cleaning Validation/verification or supporting studies of same would be advantageous
  • Experience of authoring CMC sections of regulatory submissions would be advantageous
  • Capable of presentation of overview/playbooks to support internal and Regulatory audits
  • Experience of Technology Transfer activities is advantageous
  • Knowledge or experience of start-up or systems would be ideal

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Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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