Ecocareers · 3 months ago
GXP Validation Analyst
Highland Heights, KY
Full-time
Onsite
Senior Level
6+ years expEcocareers is a company focused on the validation of software for laboratory instrumentation. The GXP Validation Analyst will be responsible for documenting and validating software according to EMA guidelines, as well as ensuring compliance with internal SOPs and managing software requirements for lab instruments.
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