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.