Validation Specialist

The Validation Specialist will be responsible for designing, executing, and closing validation protocols while ensuring compliance with current Good Manufacturing Practices (cGMPs). This role requires both independent and team-based work, interfacing with various levels of the organization to maintain regulatory standards and support validation and calibration activities.

• Develop and implement validation and calibration strategies, ensuring effective communication across the facility.
• Establish and maintain validation policies and procedures to comply with global regulations and standards.
• Direct and coordinate validation and calibration activities across multiple functional areas.
• Support and participate in regulatory inspections, audits, and collaborate with internal and external partners to resolve compliance issues.
• Author, review, and manage equipment calibration protocols, validation reports, and related documentation.
• Participate in project teams focused on validation and calibration initiatives, proactively identifying and resolving issues.
• Prepare and manage documentation for installation, operational, and performance qualifications, as well as change control and deviation reports.
• Assist in the development of validation master plans, computerized system validation, and other technical specifications and reports.

• Bachelor’s degree in Engineering or a relevant scientific discipline preferred.
• 3-5 years of relevant experience performing validations in a pharmaceutical or manufacturing environment.
• Experience with cGMP activities required.
• Strong accountability and ability to work collaboratively to achieve objectives.
• Experience coordinating with vendors and contractors.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office applications, especially Word and Excel.
• Strong scheduling and time management skills for daily operations and special projects.
• Knowledge of cGXP and scientific writing/terminology.

Quality & Validation