Validation Analyst (IQ, OQ, PQ)

Company: ALTA IT Services
Location: Bethesda
Posted on: May 8, 2025

Job Description:

VALIDATION ANALYST (IQ, OQ,PQ)

Ensure you read the information regarding this opportunity thoroughly before making an application.
US CITIZENSHIP REQUIRED
100% REMOTE
HOURLY RATE: $40/HR range. W2, Benefits Available

ALTA IT Services has a contract opening for a Validation Analyst to join our client in a 100% remote role supporting EST work hours. This is a 6+ month project.

Duties and Responsibilities: Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, or processes.
Perform risk assessments and define validation strategies based on system impact.
Document validation activities following regulatory standards (e.g., FDA, EMA, GxP, 21 CFR Part 11).
Collaborate with cross-functional teams (QA, IT, Manufacturing, Engineering) to gather requirements and ensure validation readiness.
Support audits and inspections by providing validation documentation and responses.
Maintain validation lifecycle documentation, including validation plans, reports, deviations, and change controls.
Track and manage validation deliverables and timelines for projects.
Stay current with industry best practices and regulatory changes


Required Skills/Certifications: Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
Experience in validation (equipment, process, software, or computer systems).
Familiarity with regulatory guidelines (GxP, 21 CFR Part 11, Annex 11, etc.).
Strong analytical, documentation, and problem-solving skills.
Attention to detail and ability to manage multiple validation projects.
Excellent communication and organizational skills


Preferred Skills/Certifications: Experience with computerized system validation (CSV).
Knowledge of validation in regulated environments (e.g., pharmaceutical, biotech, medical devices).
Proficiency in validation tools and documentation software.
Relevant certifications (e.g., ISPE, ASQ, or CSV certifications).


Min Citizenship Status Required: US Citizen
Location: Remote, US (EST)

HOURLY RATE: $40/HR range. W2, Benefits Available


Ref: #855-IT Baltimore

Keywords: ALTA IT Services, Bethesda , Validation Analyst (IQ, OQ, PQ), Professions , Bethesda, Maryland