Validation Lead

As a Validation Lead , you will oversee validation activities to ensure systems, equipment, processes, and software comply with regulatory, quality, and operational requirements. You will collaborate with cross-functional teams to develop validation strategies, execute validation protocols, and maintain compliance within highly regulated environments. This role is ideal for professionals who possess strong technical expertise, leadership capabilities, and a commitment to quality and continuous improvement.

Key Responsibilities:

1. Lead validation activities for equipment, systems, processes, and software throughout their lifecycle.
2. Develop, review, and approve validation plans, protocols, reports, and supporting documentation.
3. Coordinate validation projects with engineering, quality, manufacturing, and regulatory teams.
4. Ensure compliance with applicable regulatory requirements, industry standards, and company policies.
5. Investigate validation deviations and implement corrective and preventive actions (CAPAs).
6. Support audits, inspections, and continuous improvement initiatives related to validation programs.

Qualifications:

1. Bachelor's degree in Engineering, Life Sciences, Quality Assurance, or a related field.
2. 5+ years of experience in validation, quality, compliance, or regulated manufacturing environments.
3. Strong knowledge of validation methodologies, including IQ/OQ/PQ and computerized system validation.
4. Experience working within FDA, GMP, ISO, or other regulated industry environments.
5. Excellent project management, analytical, and documentation skills.
6. Strong communication, leadership, troubleshooting, and problem-solving abilities.

Benefits:

• Comprehensive Medical, Dental, and Vision Insurance
• 401(k) Retirement Savings Plan with Company Match
• Paid Time Off (PTO) and Paid Holidays
• Life and Disability Insurance
• Professional Development and Certification Reimbursement
• Flexible Work Arrangements
• Employee Assistance Program (EAP)
• Career Advancement Opportunities
• Performance-Based Bonus Programs
• Tuition Assistance Programs