Business Systems and Validation Analyst III

What you'll do

• Gather, analyze, and document business, user, and system requirements for laboratory instrumentation and computerized systems.
• Develop and maintain SDLC documentation including risk assessments, traceability matrices, and validation reports.
• Create, execute, and manage validation test cases for laboratory software and equipment.
• Support the implementation, upgrade, and lifecycle management of laboratory software across multiple business units.
• Represent the instrument validation program during client, regulatory, and internal audits.
• Lead process improvement initiatives to enhance validation efficiency, standardization, and compliance optimization.
• Author and maintain SOPs, work practices, and technical documentation for regulatory requirements.
• Provide technical guidance, mentorship, and training to junior team members on SDLC processes and validation methodologies.

What we're looking for

• Bachelor's degree or equivalent relevant formal academic or vocational qualification.
• At least 5 years of experience in software development, validation, or a regulated laboratory environment (or equivalent education and training).
• Experience with computerized system validation and SDLC processes within a regulated environment.
• Experience gathering business and system requirements for laboratory software or instrumentation.
• Experience supporting client, regulatory, or internal audits.
• Proficiency in MS Office is required.
• Experience authoring SOPs, leading process improvements, mentoring junior staff, or supporting laboratory systems (preferred).