Senior Validation Analyst

Description

Job Summary: Senior Validation Analyst playing a pivotal role in elevating the methodological standards of validation studies, serving as the technical reference in Cleaning, Process, and Computerized Systems Validation. Key Highlights: 1. Technical reference in Cleaning, Process, and Computerized Systems Validation 2. Experience in a regulated environment focused on continuous improvement 3. Technical autonomy, critical thinking, and collaborative attitude We are seeking a Senior Validation Analyst to serve as the technical reference in Cleaning Validation, Process Validation, and Computerized Systems Validation, contributing to the consolidation of practices aligned with major regulatory guidelines (MAPA, ANVISA, FDA, and Eudralex). This professional will play a pivotal role in elevating the methodological standards of validation studies, ensuring technical consistency, risk-based perspective, and sustainability of the validation system throughout the lifecycle of processes and systems. We are a technical team with strong interfaces with Production, Engineering, and Quality Assurance, operating in a regulated environment focused on continuous improvement. We value technical autonomy, critical thinking, and a collaborative attitude. We are always looking for unique talents to join and become part of our team—professionals passionate about what they do and who identify with our beliefs. **We are Ourofino.** **Responsibilities and Duties** **What You Will Do:** * Serve as the technical reference in Cleaning Validation, Process Validation, and Computerized Systems Validation. * Develop, review, and structure protocols, reports, and risk analyses based on applicable regulatory guidelines. * Conduct highly complex technical studies, ensuring methodological robustness and documentary consistency. * Provide technical support to intermediate and junior analysts in carrying out their activities, contributing to team development. * Actively participate in internal and external audits, providing technical support in the disciplines under your responsibility. * Critically evaluate validation strategies and propose improvements and standardizations when necessary. * Manage multiple projects simultaneously from a technical standpoint, ensuring deadlines are met and deliverables maintain high quality. * Contribute to consolidating a risk-based approach across validation disciplines. **Requirements and Qualifications** **What You Need to Have:** * Bachelor’s degree in Pharmacy, Chemistry, Biology/Biotechnology, or Engineering. * Proven experience as a Senior Validation Analyst in a regulated environment. * Applied knowledge of ANVISA, FDA, and Eudralex guidelines related to validation disciplines. * Experience with risk analysis (e.g., FMEA, GAMP, FTA) applied to processes, systems, or cleaning. * Hands-on experience in developing and reviewing technical validation documentation. * Ability to work with technical autonomy, critical thinking, and well-founded technical argumentation. * Organizational and priority management skills, technical influence, and a collaborative attitude committed to quality and continuous improvement. **Additional Information** **What We Offer:** Health Insurance Dental Insurance Life Insurance Private Pension Plan Meal Voucher or On-site Cafeteria Food Allowance Chartered Transportation or Transportation Voucher Pharmacy Benefit Program Wellhub (Gympass) and/or Gym Membership Zenklub Childcare Assistance for Mothers Health Monitoring Program for Pregnant Women, Women Trying to Conceive, and Adoptive Parents Short-Term Incentive Program Corporate Learning Platform Christmas Bonus Our purpose is to **Reimagine Animal Health**, challenging conventional thinking to lead the evolution and sustainable growth of the animal health ecosystem. We go beyond with our values: **Play to Win**, **Care for People**, and **Connect with the World**, generating sustainable and innovative solutions. We are one of the most admired animal health companies in Latin America. **And future members of the Ourofino Team are essential to our constant evolution.** We are always seeking **unique talents**, **passionate professionals**, and those who identify with our beliefs. Take the opportunity to learn more about our story through the **Culture and Values eBook**, as well as our tips on **self-development** and **professional journey.** Access: Our Values Also explore our roadmap: Career Path