Validation Specialist II presso Albany Molecular Research, Inc.

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.

Key responsibilities include conducting computer system validations to ensure adherence to GxP regulations, including 21 CFR Parts 210, 211, and 820, as well as compliance with Good Automated Manufacturing Practice (GAMP) standards. Ensures that change controls, records, and procedures align with current Good Manufacturing Practices (cGMP) and regulatory expectations. Coordinates validation activities with cross-functional teams to minimize impact on production schedules while ensuring timely execution. Responsible for authoring validation protocols, final reports, and technical summaries for the qualification and release of equipment, systems, instruments, components, and utilities. Support continuous improvement initiatives and provide mentorship to junior validation staff.

Specifically, the Validation Specialist II will perform the following duties:

•    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, analyzing 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; and 
•    Read/interpret SOPs to ensure compliance and maintain up-to-date trainings.

REQUIREMENTS     A Bachelor’s degree in Mechanical Engineering or a related technical field with three (3) years of experience as a validation engineer, which includes 1 year of experience with the following:  

•    Resolving protocol exceptions and deviations;
•    Developing Standard Operating Procedures (SOPs), process workflows, and validation;  
•    Managing validation activities to minimize impact on production schedules; and 
•    FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, and GAMP 4 and 5 based on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance.

                                 OR

A Master’s Degree in Mechanical Engineering, or a related field, with one (1) year of experience as a validation engineer, which includes 1 year of experience with the following:  

•    Resolving protocol exceptions and deviations;
•    Developing Standard Operating Procedures (SOPs), process workflows, and validation;  
•    Managing validation activities to minimize impact on production schedules; and 
•    FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, and GAMP 4 and 5 based on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance.

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.