Validation Specialist III

Curia • Albuquerque, NM

2d

About The Position

The Validation Specialist III is a senior-level professional who leads the development, review, and execution of complex validation protocols supporting manufacturing, quality, and regulatory compliance. The role provides advanced technical expertise and strategic guidance for equipment, process, system, and computer system validations in accordance with cGMP, FDA regulations, and industry standards such as GAMP. The specialist leads cross-functional projects, coordinates validation activities across departments, and works to align validation efforts with production and quality timelines.

The position authors and approves validation master plans, protocols, and technical reports; drives improvements to validation processes; mentors junior staff; and supports regulatory inspections and audits. It also manages validation-related investigations and deviations, collaborates with external vendors and regulatory bodies, and contributes to validation strategies and organizational readiness for new product introductions and regulatory submissions. The role is based in Albuquerque, New Mexico. The employee may work in an office, manufacturing, or warehouse environment, and aseptic gowning and task-dependent personal protective equipment may be required in sterile manufacturing areas.

Requirements

• Bachelor’s degree in Computer Engineering, Physical Sciences, or a relevant field of study.
• At least five years of validation-related work experience.
• Knowledge of FDA regulations, ISO 9000-3, PIC/S guidelines for cGMP, GAMP 4 and 5 based on the GAMP V-Model Framework, and EU GMP Annex 11 for computer systems compliance.
• Ability to read and interpret safety instructions, standard operating procedures, technical procedures, and governmental regulations.
• Strong written and verbal communication and presentation skills.
• Proficiency in arithmetic across units of measurement, including whole numbers, fractions, decimals, and percentages; strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, draw valid conclusions, and interpret technical instructions in mathematical or diagram form while handling abstract and concrete variables.
• Strong attention to detail and proficiency in advanced mathematics, such as calculus, and technical writing.
• Must pass a background check and drug screen; may be required to pass Occupational Health Screening.
• Must obtain and maintain gowning certification and may be required to obtain and maintain media qualification.
• Ability to meet the position’s physical demands, which may include lifting, pushing, or pulling, and regular sitting, standing, reaching, and other occasional physical activities.

Responsibilities

• Lead development, execution, and review of complex validation protocols, including computer system validation, manufacturing equipment qualification, packaging equipment validation, and lyophilizer qualification.
• Author, maintain, and approve validation master plans in compliance with regulatory requirements and industry standards.
• Oversee and conduct validation testing; analyze data for accuracy, reliability, and compliance; and prepare final reports with recommendations for adjustments or corrective actions.
• Coordinate cross-functional validation activities with production and quality teams to meet project timelines with minimal disruption.
• Provide technical guidance and mentorship on equipment installations, system modifications, and validation practices to junior and mid-level staff.
• Drive continuous improvement of validation processes, procedures, and documentation standards.
• Manage relationships with external vendors and consultants supporting validation projects and ensure adherence to quality and compliance standards.
• Support regulatory inspections and audits by preparing documentation, responding to inquiries, and addressing validation-related observations.
• Develop and deliver technical training on validation methodologies, regulatory expectations, and quality standards.
• Read and interpret SOPs to ensure compliance and maintain up-to-date training.
• Participate in special projects and perform additional duties assigned by management.
• Promote a safe and healthy work environment by identifying hazards, following safety protocols, participating in safety training, and encouraging safety awareness.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior