Laboratory Engineer

Lab / LIMS Engineer (Pharma | GxP | Automation Integration) Location: Hybrid – Remote with periodic travel to client site Engagement: 12-month contract (extensions likely) Start Date: Within 2–4 weeks Hours: Full-time (40 hrs/week) Rate: Competitive (W2 or C2C + approved expenses) Position Overview Our client, a global biopharmaceutical manufacturer, is seeking a Lab / LIMS Engineer to support implementation, integration, and lifecycle management of laboratory systems within a GMP environment. This role will sit within the Digital / Automation function and act as the technical owner for LIMS and connected lab applications — enabling data integrity, automation connectivity, and paperless laboratory operations. The successful candidate will work closely with Quality, IT, and Manufacturing to design and deliver scalable, compliant laboratory informatics solutions supporting QC, analytical development, and tech transfer activities. Key Responsibilities • Serve as the technical lead for LIMS configuration, administration, and integration with analytical instruments, LES/ELN, and other lab systems. • Design, configure, and maintain LIMS master data, workflows, specifications, methods, and stability study templates. • Manage system interfaces and data exchange (e.g., Empower, Chromeleon, SAP, PI, LES, ELN, CDS). • Partner with IT and QA on CSV/CSA validation activities, authoring and reviewing URS/FRS, risk assessments, test scripts, and trace matrices. • Support deployment, upgrades, and change control for LIMS and lab systems, ensuring 21 CFR Part 11 and Annex 11 compliance. • Provide technical troubleshooting and root-cause analysis for lab system issues. • Collaborate with business stakeholders to streamline workflows and enable digital transformation within the QC labs. • Support audit and inspection readiness, providing objective evidence for system compliance. • Train end users and develop supporting SOPs, WIs, and documentation as required. Required Experience • 7+ years of experience supporting and configuring LIMS systems in the pharmaceutical/biotech industry. • Hands-on experience with at least one of: LabVantage, LabWare, SampleManager, MODA, or STARLIMS. • Demonstrated understanding of GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles. • Experience integrating LIMS with instrumentation, Empower/Chromeleon, and enterprise systems (e.g., SAP, PI, MES, ELN). • Proven ability to deliver LIMS configuration, validation, and change management documentation in GxP environments. • Excellent stakeholder management — able to communicate effectively with QC, QA, IT, and Automation teams. Preferred Skills • Exposure to cloud-hosted LIMS environments and SaaS supplier qualification. • Experience with Kneat, ValGenesis, or Veeva Vault for validation lifecycle management. • Background in automation/data integration (OSIsoft PI, OPC, or middleware tools). • Understanding of Lab Automation, LES/ELN, or robotic lab systems. • Technical degree in Computer Science, Engineering, Chemistry, or related discipline.