Ecocareers · 3 months ago
GXP Validation Analyst
Highland Heights, KY
Full-time
Onsite
Senior Level
6+ years expConfidential company is seeking a GXP Validation Analyst to support a Global Instrument Software Validation Project. The role involves documenting and validating software for lab instrumentation according to EMA guidelines and ensuring compliance with PPD IT SOPs.
Staffing & Recruiting
Responsibilities
Gather and document requirements (URS, software configuration)
Write and execute validation test cases (IQ, OQ, PQ as applicable)
Support to prepare requirements specifications, infrastructure & data flow diagrams
Perform risk assessments and ensure traceability of requirements → risks → tests → results
Support SOP migration and alignment with PPD IT practices
Communicate effectively with lab, IT, QA, and vendor teams
Qualification
Required
Strong technical writing & documentation skills
Experience in software validation (lab instruments / GxP systems)
Knowledge of EMA guidelines, Annex 11, GAMP 4
Ability to create infrastructure/data flow diagrams
Detail-oriented with strong communication and stakeholder engagement skills
6–9 years relevant validation experience (pharma / biotech / CRO )
Familiarity with CSA Principles
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase