Validation Lead - cGMP Compliance & Inspection Readiness

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

Benefits offered by this job

Health insurance (medical, dental, and

Wellness programs

Life and disability insurance

Retirement savings plans

Education-related programs

Paid holidays and vacation

Job summary

The Estée Lauder Companies Inc. is seeking a Validation Manager to lead the site validation program at the Melville facility, ensuring manufacturing processes, equipment, facilities, utilities, computerized systems, and quality systems meet cGMP requirements and regulatory standards.

You will partner with Quality, Engineering, Manufacturing, and Facilities to drive strategic validation initiatives, prepare for inspections, and push continuous improvement across the organization.

Qualifications

• BS Engineering or relevant work experience.
• Minimum 5 years of experience.
• Experience with FDA regulated industries (Medical Devices or Pharmaceutical).
• Strong oral and written communication and presentation skills.
• Experience in writing and executing protocols for complex systems.

Responsibilities

• Lead the development, implementation, and continuous improvement of the site's validation program to ensure cGMP compliance.
• Provide regulatory interpretation and align validation practices with FDA expectations.
• Support inspections, audits, and timely resolution of observations; ensure inspection readiness.
• Lead cross-functional collaboration with Quality, Engineering, Manufacturing, and Facilities.
• Mentor teams on validation policies, documentation, and change control.
• Identify opportunities to improve validation systems and processes.

Skills

Strong communication and presentation

Interpersonal skills

cGMP & Regulatory Compliance

Risk Assessment & Problem Solving

Education

BS Engineering or relevant work experience

Job description

The Estée Lauder Companies Inc. is seeking a Validation Manager to lead the site validation program at the Melville facility, ensuring manufacturing processes, equipment, facilities, utilities, computerized systems, and quality systems meet cGMP requirements and regulatory standards.

You will partner with Quality, Engineering, Manufacturing, and Facilities to drive strategic validation initiatives, prepare for inspections, and push continuous improvement across the organization.