Technical Services Specialist

Technical Services / Process Specialist – Dublin – Contract QCS Staffing are seeking Technical Services Specialists to join an important Biopharmaceutical partner, based in Dublin. This is initially a 12-month contract, with responsibility for overseeing Tech Transfers, NPI projects, and Process Improvements.This is a hybrid contract, 3 days per week on site.Tech Services Specialist responsibilities:To provide process expertise in either Upstream or Downstream Bioprocessing.To author and review process transfer documentation, gap assessments, technical protocols and reports, process validation documentation, and strategy documents. Also generate documentation protocols.Support Process Transfer activities.To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirementsTo identify and implement process improvements, e.g. yield, cycle time reductionTo provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolutionLead any key process changes using change control systemTo serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.Requirements as a Tech Services Specialist Minimum 3+ years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organizationTechnical and operational knowledge of upstream or downstream processing.Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturingAbility to drive for results independently and adapt to rapidly changing prioritiesExperience of Technology Transfer activitiesKnowledge or experience of start-up or systems would be idealPrevious experience working with electronic batch records is advantageous.If you have the above experience and are interested in more details, please apply now.