Validation Manager

Estée Lauder Companies•Melville, NY

9d•$85,000 - $132,650•Onsite

About The Position

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. Title: Validation Manager Role Summary: 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

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

Responsibilities

Lead the development, implementation, and continuous improvement of the site's validation program to ensure compliance with applicable cGMP regulations, validation requirements, and industry best practices.
Partner with the GMP Site Director to establish validation strategies and ensure validation activities effectively support manufacturing operations, facilities, utilities, equipment, and computerized systems.
Provide technical leadership and subject matter expertise on validation principles and regulatory expectations across the site.
Provide oversight to cross-functional teams to ensure compliance with documented validation policies, procedures, and regulatory requirements.
Oversee validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Performance Qualification (PPQ), cleaning validation, change control assessments, and validation-related deviations.
Ensure validation documentation is accurate, complete, and maintained in accordance with company procedures and regulatory expectations.
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 to ensure ongoing regulatory compliance.
Interpret evolving regulatory requirements and translate them into practical, sustainable solutions for site implementation.
Ensure validation practices remain aligned with current regulatory expectations and industry best practices.
Support regulatory inspections, customer audits, and internal quality audits by serving as the site's validation subject matter expert.
Prepare validation documentation, respond to regulatory inquiries, and support the timely resolution of audit observations and compliance actions.
Promote a continuous state of inspection readiness across all validation-related activities.
Partner with functional leaders to ensure validation-related training programs remain current and effectively support employee compliance with validation and cGMP requirements.
Identify opportunities to improve validation systems, documentation practices, and operational processes through continuous improvement initiatives.
Foster a culture of quality, compliance, and operational excellence throughout the organization.
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.