Job Title: Validation Specialist

Work Location: Hartford County, Connecticut

Summary:

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.

Responsibilities:

• 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.

Qualifications:

• 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.

Published Category: Quality & Validation