Associate Engagement Manager (GxP Validation Expert)
QuantiphiMatch Score
Against your primary resumeLogin to See Your Match Score
Create a free account or log in to unlock your CV match score across:
Protocol Intelligence
Data-driven signals on your job's competitivenessLog in to see why each signal reads the way it does.
Job Description
Structured overview of role & requirementsAbout This Role
Lead and execute GxP validation activities for infrastructure components including cloud platforms (AWS, Azure, GCP), virtualized environments, network, and storage systems.
Develop and review key validation documents applying GAMP 5 risk-based approach and ensure compliance with FDA 21 CFR Part 11 and EMA Annex 11 regulations.
Define and implement cloud validation strategies for GxP-compliant environments; support the validation lifecycle including reviews, requalification, and change control assessments.
Minimum Requirements
5+ years experience in GxP CSV/Validation with at least 3 years in hands-on Infrastructure Qualification.
Technical expertise with cloud qualification (AWS/Azure/GCP), virtualization (VMware/Hyper-V), and networking validation.
Experience in regulated industries such as Life Sciences, Healthcare, or Medical Devices.
Proficiency with IAM, RBAC, encryption, SIEM/logging tools, and validation documentation tools (HP ALM, Azure DevOps, Jira).
Ideal Candidate Profile
Proven ability to lead GxP infrastructure validation activities including documentation and compliance adherence under regulated environments.
Strong technical background in cloud platforms and infrastructure qualification combined with hands-on execution skills.
Experienced working collaboratively with IT/DevOps teams to manage infrastructure changes and ensure validation integrity.