GxP Validation Analyst With Technical Writers

Overview

On Site
Depends on Experience
Contract - W2
Contract - 12 Month(s)
No Travel Required

Skills

Validation Analyst
Good x Practice Validation Analy
GAMP
GxP
IQ
OQ
Risk Assessment
Technical Writing
Test Cases
Stakeholder Engagement
Pharmaceutics
Quality Assurance
PQ
Migration
Instrumentation
Verification And Validation
SOP
URS
Documentation
Data Flow
Regulatory Compliance
EMA guidelines
Annex 11
GAMP 4

Job Details

GxP Validation Analyst

Job Location:-Highland Heights, KY (Day 1 Onsite, Candidate needs to work 5 Days at the Client Office)

Note:- there is no client interview for this requirement,

Project Overview

Global Instrument Software Validation Project covering 200 unique instruments. Scope includes:

Documenting and validating software installed on lab instrumentation per EMA guidelines

Migrating and adherence of instrument software management to PPD IT SOPs

Capturing requirements, configurations, and compliance documentation

Key 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

Required Skills

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

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