Validation Specialist III

Curia • Albuquerque, NM

2d

About The Position

The Validation Specialist III is a senior-level professional responsible for leading the development, review, and execution of complex validation protocols supporting manufacturing, quality, and regulatory compliance. The role provides advanced technical expertise and strategic guidance on equipment, process, system, and computer system validations in accordance with cGMP, FDA regulations, and industry standards such as GAMP.

The specialist leads cross-functional validation projects, coordinates validation activities across departments, and integrates work with production and quality timelines. Responsibilities include authoring and approving validation master plans, protocols, and technical reports; improving validation processes; mentoring junior staff; supporting inspections and audits; and managing validation investigations and deviations. The role also collaborates with vendors and regulatory bodies and supports organizational readiness for new product introductions and regulatory submissions.

The employee may work in an office, pharmaceutical manufacturing, or warehouse environment. Manufacturing work requires aseptic gowning and task-dependent personal protective equipment. Other exposures and conditions may include cleaning agents, wet or humid conditions, confined areas, cold storage temperatures, moving mechanical parts, elevated heights, airborne particles, electrical activities, vibration, and compressed gases.

Requirements

• Bachelor’s degree in Computer Engineering, Physical Sciences, or a relevant field of study.
• Minimum of five years of validation-related work experience.
• Knowledge of FDA regulations, ISO 9000-3, PIC/S cGMP guidelines, 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, SOPs, technical procedures, and governmental regulations.
• Strong written, verbal, and presentation skills.
• Proficiency in arithmetic across units of measurement, fractions, decimals, and percentages, and a strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, draw valid conclusions, interpret technical instructions in mathematical or diagram form, and work with 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.
• May be required to obtain and maintain media qualification.

Responsibilities

• Lead the development, execution, and review of complex validation protocols for computer systems, manufacturing equipment, packaging equipment, and lyophilizers.
• Author, maintain, and approve validation master plans in compliance with applicable 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 validation activities with production and quality teams to meet timelines while minimizing disruption.
• Provide technical guidance and mentorship to junior and mid-level validation staff on equipment installations, system modifications, and validation practices.
• Drive continuous improvement in validation processes, procedures, and documentation standards.
• Manage relationships with external vendors and consultants supporting validation projects and compliance standards.
• Support regulatory inspections and audits by preparing documentation, responding to inquiries, and addressing validation-related observations.
• Develop and deliver training on validation methodologies, regulatory expectations, and quality standards.
• Participate in special projects and perform additional duties as assigned to support departmental and organizational goals.
• Read and interpret SOPs to ensure compliance.
• Maintain up-to-date training.
• Promote a safe and healthy work environment by identifying and addressing hazards, following safety protocols, participating in safety training, and fostering awareness among team members.
• Provide guidance and mentorship to team members, foster a collaborative and positive work environment, and champion change.

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