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Lab Systems Engineer

4 months ago

Harwell Oxfordshire, United Kingdom Insight Global Full time

Insight Global are looking for a Lab Systems Engineer to join one of there enterprise Pharmaceutical Manufacturing company. This candidate will sit in Harwell, 4 days per week. This role will be actively involved in the complete lifecycle for laboratory digital solutions. Mainly initial qualification and deployment, but also post-production administration, maintenance activities and system retirement. Want to apply Read all the information about this position below, then hit the apply button. The Ideal candidate should apply if they have the following:

  • Experience with lab systems, lab instruments or lab automation, implementing and maintaining laboratory systems.
  • Experience authoring and reviewing computer system validation lifecycle documents.
  • Experience with CFR21 Part11 and Annex 11 regulations.
  • Good understanding of digital network principles (segmentation, VLANs, firewall rules).
  • Solid experience with Microsoft Windows environments (client and server).
The day to day for this candidate includes:
  • Coordinate activities related to the delivery of bench-top laboratory systems for QC Labs in Harwell.
  • Work independently to develop and author System requirements, System Configuration Specification, System Administration SOP, execute test scripts following cGxP.
  • Author, review and approve lifecycle documents like Impact assessment, Regulatory applicability and criticality assessments, ERES assessments, etc.
  • Provide administrative support to operate systems and instruments including role management, access management and configuration maintenance.
  • Represent Digital Quality in system validation activities in conjunction with IT Infra, Validation and QA related to implementation of new lab systems and instrument systems and their on-going support.
  • Provide second-tier support to troubleshoot operation and interface of enterprise laboratory systems such as Chromeleon, LIMS, Logilab SDMS, MODA, etc.
  • Provide root cause analysis and triage support to resolve technical issues and deviation investigations related to the operations of lab systems.
  • Participate in the periodic reviews of the systems used in the QC Laboratories, support periodic maintenance activities on the digital systems and assist as digital administrator for the systems.
  • Onsite support will be required; 1 day remote work weekly.
  • Additional duties may be assigned from time to time.