Role: Validation Engineer I
Location: A asco, PR 00610
Duration: 9 Months

• Support computer system validation (CSV) and data integrity for FDA-regulated projects.
• Develop and implement validation documentation, protocols (FAT/SAT/IQ/OQ/PQ), and reports.
• Participate in project lifecycle activities: requirements definition, risk assessments, traceability, and testing.
• Validate and troubleshoot automated manufacturing and packaging systems, especially case packaging, serialization, and vision inspection systems.
• Ensure compliance with regulatory standards (FDA, ISO, GMP) in validation processes.
• Conduct non-conformance and CAPA investigations; document findings and resolutions.
• Oversee validation contractors and provide updates to Quality Management.
• Collaborate with cross-functional teams (Engineering, Quality Assurance, Regulatory) to improve processes.

• Regulatory Knowledge: Familiarity with FDA, ISO, GMP, OSHA, and EPA guidelines.
• Technical Expertise: Knowledge in validation processes, automated manufacturing systems, CSV lifecycle, and validation documentation (URS, FRS, SDS).
• Project Management: Strong organizational skills, Lean/Six Sigma knowledge preferred.
• Analytical Skills: Experience in statistical analysis, non-conformance investigations, and CAPA reporting.
• Software/Systems Knowledge: Experience with PC/HMI/PLC-based systems, automated packaging/serialization.
• Communication & Teamwork: Excellent cross-functional collaboration skills; proactive and self-starter.

Qualifications:

• Bachelor's degree in a related field.
• 0-3 years of relevant experience in the FDA-regulated industry.