Business Systems and Validation Analyst III
Core
Validating laboratory instrumentation and computerized systems in accordance with regulatory expectations (EMA guidelines) and internal quality standards.
Role type
Senior IC business systems and validation analyst
Builds
Compliant software management practices and validated laboratory systems
Domain
Life sciences / Regulated laboratory environment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computerized system validation (CSV), SDLC documentation, requirements gathering, risk assessment, audit support, SOP authoring, process improvement, technical writing
Preferred skills
Mentoring junior staff, laboratory instrumentation support, clinical trial operations knowledge
Technologies
MS Office
Responsibilities
Lead development and maintenance of SDLC and validation lifecycle documentation; Create and execute validation test cases for laboratory systems; Directly support client, regulatory, and internal audits; Lead process improvement initiatives focused on validation efficiency and compliance; Provide technical guidance and mentorship to junior team members; Collaborate with Quality Assurance, IT, and vendors to ensure compliant software management practices.