Job Description & Details
This is a heavy-duty QA and validation role centered around a global LabVantage LIMS upgrade in the pharma space, so expect to live and breathe compliance, data integrity, and system testing. If you know your way around 21 CFR Part 11 and can untangle complex LIMS migration workflows without breaking a sweat, you'll fit right in.
What You'll Actually Be Doing
You'll spend your days acting as the crucial bridge between QC laboratories, IT, and validation teams to ensure the upgraded LabVantage platform doesn't trip any regulatory wires. Your routine will involve reviewing user requirements, mapping out gap assessments, and tearing through test scripts or UAT execution. You will constantly triage system defects, chase down deviations, and make sure that electronic records, audit trails, and data migration verifications stay airtight from start to finish.
The Core Tech Stack
You need deep, hands-on experience with LabVantage LIMS and Computer System Validation (CSV) within a GxP-regulated environment. Fluency in IQ/OQ/PQ protocols, requirements traceability matrices, and data integrity principles like ALCOA+ are absolute non-negotiables here because the audit trails and system controls will be scrutinized heavily by stakeholders.
Interview Expectations
Expect the hiring team to present a scenario where a critical data migration error pops up during UAT right before a go-live date, asking how you would document, triage, and resolve the deviation while keeping the cross-functional teams aligned. They are secretly looking to see if you panic under audit pressure or if you systematically follow change control processes with meticulous documentation. You'll also likely be quizzed on how you handle pushback from developers or business users who want to bypass a validation step to save time.
Application Advice
Skip the generic project management fluff on your resume and double down on your exact LabVantage migration and CSV credentials. Make sure keywords like LabVantage LIMS, Computer System Validation, IQ/OQ/PQ, GxP, and 21 CFR Part 11 are front and center so you easily clear the initial ATS filters. Frame your past contract work around concrete examples of managing test scripts, requirements traceability, and resolving testing defects in heavily regulated life sciences environments.