Job Title: Computer System Validation (CSV) Engineer Location: Metropolitan Area Job Type: Full-time Industry: Pharmaceutical / Medical Devices Experience Required: 3-5 yrs Languages: Fluent in English and Spanish About the Role We are seeking an experienced Computer System Validation (CSV) Engineer to support the lifecycle of computer system validation activities within a manufacturing environment for pharmaceutical and medical device products. The ideal candidate will be responsible for developing, maintaining, and executing validation protocols and ensuring full compliance with regulatory and internal standards such as FDA regulations, 21 CFR Part 11 and Part 820. Key Responsibilities Lead the validation of computer systems, production equipment, and related procedures to ensure compliance with regulatory and business requirements.

Write and execute validation protocols including IQ, OQ, PQ, and cycle development, and prepare associated final reports.

Conduct periodic reviews of the validated state and support continuous improvement of the CSV program.

Investigate and troubleshoot validation issues; lead root cause analysis and resolution of deviations.

Develop change controls and perform risk assessments for new and existing equipment or systems.

Support documentation development including validation plans, reports, policies (SOPs), and user requirement specifications.

Prepare, compile, and review validation packages and data for internal and external audits.

Collaborate with Engineering to ensure consistency in equipment and systems qualification.

Mentor and train staff on CSV procedures, practices, and compliance standards.

Maintain a comprehensive validation matrix and ensure equipment re-validation is scheduled and executed as required.

Participate in project management activities including project charters, scheduling (MS Project), client progress reviews, and performance reporting.

Qualifications Education: Bachelor’s degree in Computer Engineering, Electrical Engineering, or Mechanical Engineering.

Experience: 3 to 5 years of hands-on CSV experience within the pharmaceutical or medical device industry.

Technical Skills: Proficient in MS Office and computerized systems such as SAP, FactoryWorks, PC Servers, and Documentum.

Strong knowledge of FDA regulations and validation requirements (21 CFR Part 11, Part 820, and related CPGs).

Languages: Strong written and verbal communication skills in both English and Spanish .

Personal Attributes: Strong documentation skills and attention to detail

Team player and self-starter with excellent communication and problem-solving abilities

Why Join Us? Opportunity to work in a regulated and innovation-driven environment

Collaborative team culture

Exposure to complex and impactful projects

Career development opportunities