Job Title: Senior Validation Engineer Computer Systems & Automation
Location: Anasco, PR - 00610
Duration: 12 Months

Job Description:

We are looking for a Senior Validation Engineer with extensive experience in validating computerized and automation systems in a regulated environment. The role involves managing the full Validation Life Cycle to ensure compliance with regulatory standards, troubleshooting system issues, and driving process improvements.

Job Duties:

• Plan, develop, and implement documentation, procedures, and training for the engineering team.
• Participate in the Validation Life Cycle, including validation plan creation, risk assessments, protocol development (FAT/SAT/IQ/OQ/PQ), and deviation management.
• Develop and execute validation documents such as URS, FRS, SDS, and traceability matrices.
• Conduct statistical analysis to support validation reports and establish sampling plans for testing and inspections.
• Troubleshoot computer and automation systems during validation runs and recommend quality improvements.
• Oversee the installation of equipment, controls, and software modifications for automated systems.
• Evaluate and document non-conformances, and manage CAPA investigations.
• Ensure compliance with FDA, GMP, ISO, OSHA, and other regulatory requirements.
• Work closely with cross-functional teams, vendors, and customers, and participate in external audits.

Skills and Qualifications:

• Strong knowledge of FDA, GMP, GAMP 5, ISO standards, OSHA, and EPA requirements.
• Expertise in Computer Systems Validation Life Cycle and related documentation (URS, FRS, IQ/OQ/PQ).
• Familiarity with Lean/Six Sigma methodologies and statistical analysis techniques.
• Project management skills, with experience in leading complex projects and cross-functional teams.
• Ability to troubleshoot system issues and implement process/quality improvements.
• Spanish language is a plus.

Education and Experience:

• Bachelor's degree in Engineering, Computer Science, or a related field.
• 7+ years of experience in validation, verification, or quality engineering in a regulated environment.
• Experience with technical documentation, change controls, and validation plans.