What You Will Achieve
- Translate business needs from laboratory and operations teams into practical information system solutions.
How You Will Achieve It
- Partner with functional assay leads, operations leads, laboratory SMEs, and informatics partners to understand business needs and define system solutions.
- Elicit, document, and maintain business and end-user requirements for new solutions and enhancements.
- Support solution design to ensure functionality aligns with laboratory workflows, operational needs, compliance expectations, and end-user requirements.
- Project manage initiatives across the solution development lifecycle (requirements gathering, design review, testing, validation readiness, deployment support, post-implementation follow-up).
- Develop, review, and execute user acceptance testing; confirm functionality meets approved business/end-user requirements.
- Guide end users through testing, support execution, document results, capture defects, and coordinate issue resolution.
- Generate/review/maintain validation documentation (requirements, test scripts, SOPs, change controls, and project deliverables).
- Facilitate stakeholder meetings to review priorities, status, risks, decisions, and action items.
- Collaborate with quality, validation, laboratory, and technical teams to meet regulated system expectations.
- Maintain compliance with departmental/site/corporate training, quality, and safety requirements.
Here Is What You Need (Minimum Requirements)
- MS/MA in a science-related discipline with 1+ years of hands-on industry experience, or BS/BA with 3+ years.
- Understanding of solution development lifecycle activities in a regulated/quality-driven environment.
- Strong written and verbal communication.
- Strong organizational skills; manage multiple priorities/timelines/stakeholders.
- Proficient in Microsoft Office 365.
Bonus Points (Preferred Requirements)
- Experience supporting validated systems in pharma/biotech/lab/regulated environments.
- Familiarity with LabWare LIMS and SAS (or similar).
- Experience creating documentation (requirements, test scripts, traceability matrices, SOPs, user guides).
- Cross-functional experience across business/quality/technical teams.
- Working knowledge of SQL and basic programming.
- Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) with responsible AI awareness.
Non-standard Schedule / Work Location
- Occasional evening/weekend work; Hybrid.
Compensation/Benefits (as stated)
- Base salary range: $82,700β$137,900; bonus target 10% (Global Performance Plan). 401(k) match and additional retirement contribution; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/prescription/dental/vision.