Validation Specialist III

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 the 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.

Education and Experience

• Bachelor's degree in Computer Engineering, Physical Sciences, or 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.

Other 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.