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About the Role

The Validation Manager is responsible for leading the site's validation program to ensure manufacturing processes, equipment, facilities, utilities, computerized systems, and quality systems comply with applicable cGMP regulations, validation requirements, and industry standards. This role provides strategic leadership and technical expertise in the development, implementation, and continuous improvement of validation processes across the Melville site while ensuring inspection readiness and regulatory compliance. The Validation Manager partners with Quality, Engineering, Manufacturing, Facilities, and other cross-functional teams to maintain a robust validation program that supports operational excellence, product quality, and successful regulatory inspections.

Responsibilities

Lead the development, implementation, and continuous improvement of the site's validation program.
Partner with the GMP Site Director to establish validation strategies.
Provide technical leadership and subject matter expertise on validation principles and regulatory expectations.
Provide oversight to cross-functional teams to ensure compliance with documented validation policies, procedures, and regulatory requirements.
Oversee validation activities, including IQ, OQ, PQ, PPQ, cleaning validation, change control assessments, and validation-related deviations.
Ensure validation documentation is accurate, complete, and maintained.
Monitor validation performance and identify opportunities to strengthen compliance, improve processes, and reduce operational risk.
Liaise with site functions such as manufacturing, planning, QA, QC, and operations.
Maintain expert knowledge of applicable FDA regulations, cGMP requirements, validation guidance, and industry standards.
Interpret evolving regulatory requirements and translate them into practical, sustainable solutions.
Ensure validation practices remain aligned with current regulatory expectations and industry best practices.
Support regulatory inspections, customer audits, and internal quality audits.
Prepare validation documentation, respond to regulatory inquiries, and support the timely resolution of audit observations.
Promote a continuous state of inspection readiness across all validation-related activities.
Partner with functional leaders to ensure validation-related training programs remain current.
Identify opportunities to improve validation systems, documentation practices, and operational processes.
Foster a culture of quality, compliance, and operational excellence.
Collaborate with Quality, and Manufacturing teams across multiple sites to share best practices, standardize validation approaches, and drive continuous improvement initiatives.
Support corporate quality initiatives and contribute to the development and implementation of enterprise-wide validation standards.

Requirements

BS Engineering or relevant work experience
5 years minimum experience
Experience with FDA regulated industries (Medical Devices or Pharmaceutical)
Strong oral and written communication and presentation skills
Experience in writing and executing protocols including complex systems such as Process Validation, cleaning validation, utilities, manufacturing equipment such as computer-controlled filling systems, formulation systems
Ability to manage complex projects and timelines in a matrix team environment.
Strong project management and organizational skills
Demonstrate interpersonal skills including strong negotiation and facilitation skills
cGMP & Regulatory Compliance
Risk Assessment & Problem Solving

Skills

cGMP & Regulatory Compliance
Risk Assessment & Problem Solving
Process Validation
Cleaning Validation
Utilities Validation
Manufacturing Equipment Validation
Computerized Systems Validation
Project Management
Organizational Skills
Negotiation Skills
Facilitation Skills
Oral Communication
Written Communication
Presentation Skills

Location

Melville

Work Type

Full-time

Experience Level

5 years minimum experience

Education Level

BS Engineering or relevant work experience

Salary/Compensations

$85,000.00 - $132,650.00

Benefits

Health insurance coverage (medical, dental, and vision insurance)
Wellness and family support programs
Life and disability insurance
Retirement savings plans
Education-related programs
Paid holidays and vacation time
Competitive incentive compensation programs
Commission/Bonus Plan

About the Company

The Estée Lauder Companies Inc. is one of the world’s leading manufacturers, marketers, and sellers of quality skin care, makeup, fragrance, and hair care products, and is a steward of luxury and prestige brands globally.
The company’s products are sold in approximately 150 countries and territories under brand names including: Estée Lauder, Aramis, Clinique, Lab Series, Origins, M·A·C, La Mer, Bobbi Brown Cosmetics, Aveda, Jo Malone London, Bumble and bumble, Darphin Paris, TOM FORD, Smashbox, AERIN Beauty, Le Labo, Editions de Parfums Frédéric Malle, GLAMGLOW, KILIAN PARIS, Too Faced, Dr.Jart+, the DECIEM family of brands, including The Ordinary and NIOD, and BALMAIN Beauty.

Equal Opportunity

We are an equal-opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
Accommodations for job applicants with disabilities are available on request.
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