Validation Specialist III

Curia; Albuquerque (NM); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Generous benefit options

Paid training, vacation, and holidays

Career advancement opportunities

401K program with matching contributions

Education reimbursement

Job summary

Curia is seeking a Validation Specialist III in Albuquerque, NM. This senior role requires leadership in developing complex validation protocols to ensure compliance with regulatory standards such as cGMP and FDA regulations. The successful candidate will mentor junior staff and drive continuous improvement initiatives.

A Bachelor’s degree in a relevant field along with 5+ years of experience in validation is required. The position offers generous benefits including a 401K program, educational reimbursement, and paid vacation.

Qualifications

• Minimum of five years of validation-related work experience.
• Knowledge of FDA regulations and cGMP compliance.
• Strong written and verbal communication skills.

Responsibilities

• Lead development and execution of validation protocols.
• Coordinate validation activities with production and quality teams.
• Mentor junior validation staff and provide technical guidance.

Skills

Technical writing

Attention to detail

Team collaboration

Regulatory compliance knowledge

Education

Bachelor’s degree in Computer Engineering or Physical Sciences

Tools

Statistical analysis software

Validation management systems

Job description

Job Description

Validation Specialist III, Albuquerque, NM

Build your future at Curia, where our work has the power to save lives.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life‑saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

Summary

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. This 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 Validation Specialist III leads cross‑functional validation projects, coordinates validation activities across multiple departments, and ensures seamless integration with production and quality timelines. This role authors and approves comprehensive validation master plans, protocols, and technical reports while driving continuous improvement initiatives to optimize validation processes.

Additionally, the Validation Specialist III mentors junior validation staff, supports regulatory inspections and audits, manages validation‑related investigations and deviations, and collaborates with external vendors and regulatory bodies. This position plays a key role in shaping validation strategies and ensuring organizational readiness for new product introductions and regulatory submissions.

Essential Duties and 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 comprehensive validation master plans ensuring full compliance with regulatory requirements and industry standards such as FDA, cGMP, GAMP, and EU GMP Annex 11.
• Oversee and conduct validation testing activities, analyze data for accuracy, reliability, and compliance, and prepare detailed final reports with recommendations for adjustments or corrective actions.
• Lead cross‑functional collaboration to coordinate and integrate validation activities with production and quality teams, ensuring projects meet timelines with minimal disruption.
• Provide expert technical guidance and mentorship on new equipment installations, system modifications, and validation best practices to junior and mid‑level validation staff.
• Drive continuous improvement initiatives focused on enhancing validation processes, procedures, and documentation standards.
• Manage relationships with external vendors and consultants to support 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 and support to personnel on validation methodologies, regulatory expectations, and quality standards.
• Participate in special projects and perform additional duties as assigned by management to support departmental goals and organizational objectives.
• Read/interpret SOPs to ensure compliance.
• Maintain up‑to‑date trainings.
• Other duties as assigned.

Education and Experience

• Bachelor’s degree in Computer Engineering, Physical Sciences, or a relevant field of study.
• Minimum of five (5) years validation‑related work experience.
• Knowledge of regulatory requirements, including 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.

Language Skills

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical Skills

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Supervisory Responsibilities

This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

Additional Skills and Abilities

• Provides guidance and mentorship to team members.
• Fosters a collaborative and positive work environment.
• Champions change.
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail.
• Proficiency in advanced mathematics (e.g., calculus) and technical writing.

Other Qualifications

• Must pass a background check.
• Must pass a 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.

Physical Demands

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity.

Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons.

Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, cleanroom socks, face shields, safety glasses, aprons, steel‑toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.

Equal Opportunity Employment

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. Curia is an E‑Verify employer.