Senior LIMS QA Engineer (GxP / CSV)

TL;DR

Senior LIMS QA Engineer (GxP / CSV): Leading validation and testing for LIMS applications and laboratory systems with an accent on GxP, CSV, and 21 CFR Part 11 compliance. Focus on developing and executing end-to-end validation deliverables and ensuring audit readiness in regulated environments.

Location: Hybrid (3 days/week onsite in Malvern, PA, USA). Must be legally authorized to work in the United States without company sponsorship.

Salary: $71,100–$112,500 annually

Company

hirify.global is a leading global professional services company that transforms client businesses through technology for the digital era.

What you will do

• Lead validation and testing activities for LIMS platforms.
• Develop and execute end-to-end validation deliverables.
• Oversee, review, and guide the creation of validation test scripts.
• Validate LIMS integrations, interfaces, workflows, and data migration activities.
• Partner closely with stakeholders to ensure successful delivery and risk mitigation.

Requirements

• 10+ years of experience in software testing, with at least 4–5 years as a LIMS Test Lead in regulated environments.
• Strong hands-on experience with LIMS platforms such as LabWare, Thermo Fisher SampleManager, STARLIMS, or Empower.
• Proven expertise in GxP regulations (GMP, GLP, GCP), Computer System Validation (CSV), and 21 CFR Part 11.
• Deep understanding of data integrity principles (ALCOA+).
• Extensive experience with validation lifecycle activities including test strategy, planning, and IQ/OQ/PQ testing.
• Proficiency with test management and defect tracking tools such as JIRA/Xray.
• Legally authorized to work in the United States without company sponsorship.

Nice to have

• Exposure to GenAI platforms or the use of AI-enabled tools in testing or documentation.
• Experience validating complex interfaces, reporting solutions, and multi-system data flows.
• Familiarity with data migration validation and large-scale laboratory system deployments.

Culture & Benefits

• Hybrid work model with flexibility and various wellbeing programs.
• Medical/Dental/Vision/Life Insurance.
• Paid holidays plus Paid Time Off.
• 401(k) plan and contributions.
• Long-term/Short-term Disability and Paid Parental Leave.
• Employee Stock Purchase Plan.