**Job Summary**:
**Key Responsibilities**:
**Validation & Compliance**:
- Develop, execute, and maintain **Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)**protocols for manufacturing equipment, processes, and software.
- Ensure compliance with **FDA 21 CFR Part 820, ISO 13485, GMP, and GAMP 5**regulatory requirements.
- Conduct **risk assessments**and implement **Corrective and Preventive Actions (CAPA)**to address validation gaps.
- Support internal and external **audits and regulatory inspections**by providing validation documentation and expertise.
**Testing & Documentation**:
- Design and perform **validation studies, data analysis, and process capability assessments**to confirm equipment and system reliability.
- Maintain comprehensive **validation documentation**, including protocols, reports, and traceability matrices.
- Collaborate with **Quality Assurance (QA), Regulatory Affairs, and Engineering teams**to ensure validation compliance.




**Process Improvement & Leadership**:
- Identify opportunities for **process optimizations**and implement validation best practices.
- Lead cross-functional teams in validation activities and provide training to junior engineers and technicians.
- Develop and maintain **Standard Operating Procedures (SOPs)**related to validation processes.
**Qualifications & Experience**:
- **Bachelor’s or Master’s degree**in Engineering, Life Sciences, or a related field.
- **5+ years**of experience in validation within the **medical device industry**.
- Strong understanding of **ISO 13485, FDA regulations, GMP, and risk management methodologies**.
- Experience with **validation software, automation tools, and statistical analysis**.
- Excellent **problem-solving, project management, and communication skills**.

📌 Senior Validation Engineer (Tijuana)
🏢 Talent Connect Now
📍 Tijuana