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. Bachelors 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