GxP Validation Analyst

Overview

On Site
Accepts corp to corp applications
Contract - W2
Contract - Independent
Contract - Long term

Skills

Pharma
Validation
IQ
GXP
Biotech
OQ
PQ

Job Details

Hello,

Hope you are doing well,

GxP Validation Analyst

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

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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

About Amaze Systems Inc