Validation Analyst

Spectraforce Technologies; New York (NY); Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative firm is seeking a Validation Analyst for a 6+ month remote project. This role involves developing and executing validation protocols for equipment and processes, ensuring compliance with regulatory standards. The ideal candidate will collaborate with cross-functional teams, maintain validation documentation, and support audits. If you have a strong background in validation and are detail-oriented, this opportunity to make a significant impact in a dynamic environment is perfect for you.

Qualifications

• Bachelor's degree in relevant field required.
• Experience in validation of equipment, processes, or systems.

Responsibilities

• Develop and execute validation protocols for systems and processes.
• Document validation activities per regulatory standards.

Skills

Validation Protocols (IQ, OQ, PQ)

Risk Assessments

Regulatory Standards (FDA, EMA, GxP)

Analytical Skills

Documentation Skills

Problem-Solving Skills

Attention to Detail

Communication Skills

Organizational Skills

Education

Bachelor's degree in Life Sciences

Bachelor's degree in Engineering

Bachelor's degree in Computer Science

Tools

Validation Tools

Documentation Software

Job description

Validation Analyst

100% remote (EST work hours)

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 in accordance with 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).