Validation Lead

Job in Durham, Durham County, North Carolina, 27703, USA

Listing for: Stella Contracting, Inc

Full Time position
Listed on 2026-06-16

Job specializations:

Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, QA Specialist / Manager
Engineering
Regulatory Compliance Specialist, Quality Engineering, QA Specialist / Manager

Salary/Wage Range or Industry Benchmark: 85000 - 110000 USD Yearly USD 85000.00 110000.00 YEAR

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:

Lead validation activities for equipment, systems, processes, and software throughout their lifecycle.

Develop, review, and approve validation plans, protocols, reports, and supporting documentation.

Coordinate validation projects with engineering, quality, manufacturing, and regulatory teams.

Ensure compliance with applicable regulatory requirements, industry standards, and company policies.

Investigate validation deviations and implement corrective and preventive actions (CAPAs).

Support audits, inspections, and continuous improvement initiatives related to validation programs.

Qualifications:

Bachelor's degree in Engineering, Life Sciences, Quality Assurance, or a related field.

5+ years of experience in validation, quality, compliance, or regulated manufacturing environments.

Strong knowledge of validation methodologies, including IQ/OQ/PQ and computerized system validation.

Experience working within FDA, GMP, ISO, or other regulated industry environments.

Excellent project management, analytical, and documentation skills.

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

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