Validation Specialist II

Overview

Curia Global, Inc. (Albuquerque, NM) Validation Specialist II. Responsible for developing, reviewing, and executing validation protocols to support manufacturing and quality operations while ensuring compliance with regulatory requirements. Provides technical expertise and guidance on equipment, component, process, and system validation activities, collaborating closely with production and quality teams.

Responsibilities

• Develops, executes, and reviews validation protocols, including computer system validation, manufacturing equipment qualification, packaging equipment validation, and lyophilizer qualification.
• Authors validation master plans and ensures compliance with regulatory and industry standards.
• Conducts and oversees validation testing, analyzes data to assess the accuracy, reliability, and compliance of equipment, systems, instruments, and procedures. Prepares and reviews final reports, recommending adjustments or corrective actions as needed.
• Collaborates with cross-functional teams to coordinate validation activities, ensuring timely completion with minimal impact on production schedules.
• Provides technical guidance on new equipment, system modifications, and validation best practices.
• Supports regulatory compliance by developing and refining validation procedures, recommending policy improvements, and ensuring adherence to FDA, cGMP, GAMP, and EU GMP Annex 11 requirements.
• Engages with external vendors and consultants as needed for validation projects.
• Provides technical training and support to personnel on validation processes and regulatory expectations.
• Performs additional duties as assigned by management, including participation in special projects and continuous improvement initiatives.
• Read / interpret SOPs to ensure compliance and maintain up-to-date trainings.

Qualifications

Resolving protocol exceptions and deviations;

Resolving protocol exceptions and deviations;

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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