Software V&V Engineer

Description:

REPORTS TO

Manager, Lab IT Business Analysts

JOB DESCRIPTION

The Lab IT Senior Business Analyst at Hologic Oncology serves as a key liaison between Laboratory Operations and Information Technology, partnering with laboratory, quality, bioinformatics, and technical teams to deliver solutions that support a CLIA- and CAP-accredited molecular diagnostics laboratory.

This full-time, on-site role in San Diego, CA, is responsible for leading requirements gathering, workflow analysis, system implementations, and validation activities for laboratory technology initiatives. Areas of focus include LIS enhancements, molecular assay onboarding, NGS workflow integrations, EMR integrations, workflow optimization, and regulatory compliance. The Senior Business Analyst translates complex business needs into scalable solutions while ensuring alignment with operational, technical, and quality requirements.

The ideal candidate combines strong business analysis skills with experience in regulated laboratory environments. Hands-on experience in molecular diagnostics, genomics, or NGS laboratories is highly preferred. Success in this role requires strong communication and stakeholder management skills, the ability to navigate ambiguity and changing priorities, and a collaborative approach to driving complex initiatives from concept through implementation.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead requirements gathering, process analysis, and documentation for laboratory technology initiatives.
• Translate business needs into user stories, process flows, and acceptance criteria.
• Support laboratory system integrations, including interfaces between LIS, EMR/EHR platforms, laboratory instruments, bioinformatics pipelines, and enterprise applications.
• Partner with laboratory, quality, bioinformatics, and IT teams to implement and enhance laboratory systems and workflows.
• Support onboarding of new assays, laboratory integrations, and expansion of NGS capabilities.
• Participate in mergers and acquisitions activities, including integration of laboratory workflows, assays, and systems.
• Support Computer System Validation (CSV) activities, including documentation, testing, and traceability.
• Ensure solutions comply with CLIA, CAP, NYDOH, HIPAA, and internal quality requirements.
• Lead or support user acceptance testing (UAT), training, and implementation activities.
• Mentor junior analysts and provide guidance on business analysis best practices.
• Identify opportunities for process improvement, automation, and operational efficiency.
• Stay updated on industry trends and emerging technologies to drive innovation in laboratory systems.

MINIMUM QUALIFICATIONS AND REQUIREMENTS

• Bachelor''s degree in Business Administration, Information Technology, Computer Science, Life Sciences, or a related field. Advanced Degree preferred.
• Minimum 3 years of Business Analyst, Systems Analyst, or LIS Analyst experience.
• Minimum 3 years of experience working in a CLIA-regulated laboratory setting required.
• Experience gathering requirements and delivering technology solutions in regulated environments.
• Experience creating user stories, process maps, functional requirements, and test documentation.
• Experience supporting Computer System Validation (CSV) and SDLC processes.
• Strong communication, facilitation, and stakeholder management skills.

PREFERRED QUALIFICATIONS

• Hands-on experience in a molecular diagnostics, genomics, oncology, or NGS laboratory.
• Clinical Laboratory Scientist (CLS/MLS/MT) or equivalent laboratory background.
• Experience implementing or supporting NGS workflows and laboratory system integrations.
• Experience supporting EMR/EHR integrations in a clinical or laboratory environment.
• Experience onboarding new assays into laboratory operations and supporting LIS workflows.
• Experience supporting laboratory mergers, acquisitions, or multi-site integrations.
• Experience with SCC Soft Computer products, Salesforce, and Epic.
• Experience mentoring junior analysts or leading workstreams on complex projects.

Intake Notes:

Position Overview

• Role: Software V&V Engineer
• Location: San Diego, CA (GCD2 Biotheranostics Site)
• Work Arrangement: 100% Onsite
• Schedule: Monday-Friday, 8-hour days
• Hours: 40 per week
• Assignment Duration: 1 Year
• Extension Possible: Yes
• Conversion Possible: Yes
• Target Start Date: 11/30/2026
• Hiring Manager would like the worker fully onboarded before planned leave in early February.

Key Responsibilities

• Lead requirements gathering, workflow analysis, and documentation for laboratory technology initiatives.
• Create user stories, process flows, functional requirements, and acceptance criteria.
• Support LIS enhancements, system integrations, assay onboarding, and laboratory workflow improvements.
• Partner with Laboratory Operations, Quality, Bioinformatics, and IT teams to implement technology solutions.
• Support onboarding of new assays and expansion of NGS capabilities.
• Participate in mergers and acquisitions activities involving laboratory systems and workflows.
• Support Computer System Validation (CSV), testing, traceability, and documentation efforts.
• Lead or support User Acceptance Testing (UAT), implementation activities, and training.
• Identify opportunities for process improvement, automation, and operational efficiency.
• Mentor junior analysts and provide guidance on business analysis best practices.

Required Skills

• 3+ years Business Analyst, Systems Analyst, or LIS Analyst experience.
• 3+ years supporting a CLIA-regulated laboratory environment.
• Strong requirements elicitation and documentation experience.
• Hands-on Computer System Validation (CSV) experience including test scripts, validation documentation, traceability matrices, deviations, and UAT.
• Experience developing user stories, process maps, functional requirements, and acceptance criteria independently.
• Knowledge of CLIA, CAP, and HIPAA requirements.
• Ability to facilitate discussions across Lab Operations, Quality, Bioinformatics, and IT stakeholders.
• Strong stakeholder management and communication skills.
• Must be able to work onsite full-time in San Diego.

Preferred Skills

• Molecular diagnostics, genomics, oncology, or NGS laboratory experience.
• CLS/MLS/MT or equivalent laboratory background.
• Experience supporting NGS workflows and bioinformatics integrations.
• Experience supporting EMR/EHR integrations including Epic or HL7 interfaces.
• SCC Soft Computer experience.
• Experience onboarding assays into laboratory operations.
• M&A integration experience.
• Experience mentoring analysts or leading complex workstreams.
• Advanced degree preferred.

Resume Review Guidance

• Reject candidates without regulated laboratory experience.
• Reject candidates who list CSV experience but cannot demonstrate ownership of validation activities.
• Reject candidates whose experience is primarily project coordination rather than business analysis.
• Strong preference for candidates who demonstrate ownership of deliverables and end-to-end project execution.
• Candidates with CLS/MLS backgrounds and strong LIS, instrument interface, or assay validation experience may be considered even if formal BA experience is lighter.

Interview Process

• Manager review of resumes.

• Interview process to focus heavily on regulated laboratory experience, CSV ownership, stakeholder management, and requirements gathering experience.

• Manager seeking candidates with demonstrated ability to function independently in a CLIA/CAP environment.

• Via Teams

PPE Requirements

• PPE required only when working within laboratory areas.
• Must comply with laboratory safety and security requirements.
• Business casual in office environments.

Pay / Budget

• Range: $$$$ - $$$$/hr.
• Range: $$$$ - $$$$/hr.

Additional Notes

• Supports a team of 5 immediate Lab IT team members and 60+ end users.
• Primary stakeholders include Laboratory Operations, Pathologists, Quality Assurance, Bioinformatics, IT, and SCC Soft Computer vendor teams.
• Success within the first 90 days includes independently gathering requirements, supporting validation efforts, driving initiatives through UAT, and becoming a trusted partner to laboratory stakeholders.
• Focus sourcing efforts on candidates with direct CLIA-regulated laboratory systems experience, LIS experience, CSV ownership, and NGS or molecular diagnostics exposure.
• Candidates from pure healthcare payer, claims, revenue cycle, or commercial pharma backgrounds without laboratory operations experience should not be submitted.

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Additional Details

• Is this contractor required to track project codes for the work outlined in this Job Posting? : No