Validation Leader: cGMP Compliance & Regulatory Readiness

The Estée Lauder Companies Inc.; Melville (NY); On-site; USD 85,000 - 133,000; Full time

Benefits offered by this job

Health insurance

Retirement savings plans

Education-related programs

Paid holidays and vacation time

Incentive compensation programs

Job summary

The Estée Lauder Companies Inc. in Melville, NY seeks a Validation Manager to lead the site's validation program, ensuring compliance with cGMP, regulatory standards, and industry best practices across manufacturing, facilities, utilities, and computerized systems.

You will partner with Quality, Engineering, Manufacturing and Facilities to drive inspection readiness, continuous improvement, and dependable documentation, while guiding IQ/OQ/PQ/PPQ activities and risk assessments.

Qualifications

• Experience in FDA-regulated industries (Medical Devices or Pharmaceutical).
• Strong oral and written communication and presentation skills.
• Experience in writing and executing protocols for complex systems (Process Validation, cleaning validation, utilities, manufacturing equipment).
• Ability to manage complex projects and timelines in a matrix environment; strong organizational skills.
• Demonstrate negotiation and facilitation skills; regulatory compliance focus.

Responsibilities

• Lead the development and continuous improvement of the site's validation program to ensure cGMP compliance.
• Partner with GMP Site Director to shape validation strategies supporting operations, facilities, utilities, and computerized systems.
• Provide technical leadership on validation principles and regulatory expectations site-wide.
• Oversee IQ/OQ/PQ/PPQ, cleaning validation, change controls, and validation-related deviations.
• Ensure validation documentation is accurate and maintained per procedures and regulatory expectations.
• Monitor performance and drive improvements to reduce risk and strengthen compliance.
• Collaborate with manufacturing, QA, QC, planning, and operations across site functions.

Skills

Project management

Communication skills

cGMP knowledge

Regulatory compliance

Problem solving

Cross-functional collaboration

Education

BS Engineering

Job description

The Estée Lauder Companies Inc. in Melville, NY seeks a Validation Manager to lead the site's validation program, ensuring compliance with cGMP, regulatory standards, and industry best practices across manufacturing, facilities, utilities, and computerized systems.

You will partner with Quality, Engineering, Manufacturing and Facilities to drive inspection readiness, continuous improvement, and dependable documentation, while guiding IQ/OQ/PQ/PPQ activities and risk assessments.