Validation Specialist

Master Compliance; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a highly skilled Computer Software Validation Engineer who is bilingual in English and Spanish. This fully remote role involves supporting software validation in a regulated life sciences environment. The ideal candidate will lead validation activities, develop essential documentation, and ensure compliance with regulatory standards. You will collaborate with cross-functional teams, conduct quality audits, and provide guidance on validation processes. If you have a passion for quality assurance and thrive in a remote, cross-cultural environment, this opportunity is perfect for you.

Qualifications

• 7+ years of experience in Computer Software Validation in pharma or biotech.
• Strong experience with CSA, CSV, and SDLC methodologies.

Responsibilities

• Lead validation activities for computer systems in compliance with CSA principles.
• Develop validation deliverables including Validation Plans and Test Scripts.

Skills

Computer Software Validation

Bilingual (English/Spanish)

Computer Software Assurance

Quality Systems

Regulatory Compliance

Documentation Skills

Organizational Skills

Communication Skills

Education

Bachelor’s degree in Engineering, Life Sciences, or Computer Science

Tools

Veeva QMS

TrackWise

MasterControl

Kneat

Job description

Direct message the job poster from Master Compliance

Director of Recruitment & Sales - Pharma, Lifesciences & Medical Devices

Job Title: Computer Software Validation (CSV) Engineer – Bilingual (English/Spanish)

Location: Remote (U.S or South America -based)

Job Type: Contract

Position Summary:

We are seeking a highly skilled Computer Software Validation (CSV) Engineer who is bilingual in English and Spanish to support software validation activities in a regulated life sciences environment. The ideal candidate will have hands-on experience with Computer Software Assurance (CSA) approaches, validation lifecycle documentation, and a strong understanding of quality systems and regulatory compliance (FDA, GAMP 5, 21 CFR Part 11). This is a fully remote role, supporting cross-functional teams and clients in both English and Spanish-speaking environments.

Key Responsibilities:

• Lead and execute validation activities for computer systems in compliance with CSA principles, GxP, GAMP 5, and applicable regulatory guidelines.
• Develop and maintain validation deliverables, including Validation Plans, Traceability Matrices, Risk Assessments, Test Scripts (IQ/OQ/PQ), and Validation Summary Reports (VSRs).
• Support Veeva QMS implementation and validation, ensuring alignment with internal procedures and external audit readiness.
• Conduct and support internal and external quality audits, including preparation, participation, and CAPA management.
• Translate validation and quality documentation as needed to support Spanish-speaking stakeholders or client teams.
• Collaborate with cross-functional teams including QA, IT, business users, and third-party vendors to gather requirements, perform risk assessments, and support system qualification.
• Maintain documentation and evidence for inspection readiness and respond to audit findings and regulatory inquiries.
• Ensure compliance with 21 CFR Part 11, Annex 11, and data integrity principles.
• Provide guidance and training to team members and stakeholders on validation processes and CSA approaches.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field.
• Minimum 7+ years of experience in Computer Software Validation within the pharmaceutical, biotech, or medical device industry.
• Fluent in both English and Spanish (written and spoken).
• Strong experience with CSA, CSV, and SDLC methodologies.
• Proficiency with Veeva QMS and experience validating QMS or other quality software platforms.
• Strong knowledge of Validation Summary Reports, Risk Assessments, and Traceability Matrices.
• Experience working in a remote, cross-cultural environment.
• Strong organizational, documentation, and communication skills.
• Familiarity with audit protocols, regulatory inspections, and global compliance standards.
• Experience with other quality systems like TrackWise, MasterControl, or Kneat.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Quality Assurance and Consulting

Industries

Pharmaceutical Manufacturing and Biotechnology Research