What are the responsibilities and job description for the Validation Specialist position at ClinLab Solutions Group?
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
Salary : $76,000 - $90,000