Validation Analyst

Encora Inc.; Indianapolis (IN); Remote; USD 60,000 - 95,000; Full time

Job summary

An established industry player is seeking a Validation Analyst for a fully remote position supporting EST hours. In this role, you will develop and execute validation protocols for equipment and processes, ensuring compliance with regulatory standards. You'll collaborate with cross-functional teams to gather requirements and maintain validation documentation. This exciting opportunity allows you to leverage your analytical and problem-solving skills in a dynamic environment while staying current with industry best practices. If you're passionate about validation in regulated environments, this position is perfect for you.

Qualifications

• Experience in validation of equipment, processes, or software.
• Familiarity with GxP and 21 CFR Part 11 regulatory guidelines.

Responsibilities

• Develop and execute validation protocols for systems and processes.
• Collaborate with cross-functional teams to ensure validation readiness.
• Document validation activities in accordance with regulatory standards.

Skills

Validation Protocols (IQ, OQ, PQ)

Risk Assessment

Regulatory Standards (FDA, EMA, GxP)

Analytical Skills

Documentation Skills

Problem-Solving Skills

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

Encora is seeking a Validation Analyst to join us 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 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).
  
  

Min Citizenship Status Required: US Citizen

Physical Requirements: No Physical requirement needed for this position.

Location: Remote, US (EST)