Estée Lauder Companies Validation Manager
Validation Manager at Estée Lauder Companies in Melville, NY. Lead FDA compliance and manufacturing validation programs for luxury beauty products.
Role & 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
- 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
- Collaborate with Quality and Manufacturing teams across multiple sites to share best practices, standardize validation approaches, and drive continuous improvement initiatives
Qualifications
- Bachelor of Science in Engineering or equivalent relevant work experience
- Minimum 5 years of professional experience in validation or quality-related functions
- 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 including Process Validation, cleaning validation, utilities, and computer-controlled manufacturing equipment (filling systems, formulation systems)
- Ability to manage complex projects and timelines in a matrix team environment
- Strong interpersonal skills including negotiation and facilitation capabilities
- Working knowledge of cGMP and Regulatory Compliance requirements
- Experience with Risk Assessment and Problem-Solving methodologies
Skills
Experience
Minimum 5 years of professional experience in validation, quality assurance, manufacturing, or related functions within FDA-regulated industries such as medical devices or pharmaceuticals. Direct experience writing and executing validation protocols for complex manufacturing systems, cleaning validation, and utility systems required. Demonstrated success managing validation activities in a regulated environment and preparing for regulatory inspections expected.
Education
Bachelor of Science degree in Engineering or equivalent field (or relevant professional work experience may substitute for formal degree requirements).
Workplace
The successful candidate will be located in Melville, New York, USA, with easy access to New York.
Compensation
The base compensation for this position ranges from USD 85,000 to USD 132,650 per annum.
Benefits
Health insurance coverage (medical, dental, and vision), 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 eligibility (plan eligibility and guidelines to be determined at time of hire).
About Cerulean
Cerulean is the definitive career portal for the global luxury industry. We match exceptional professionals with exclusive opportunities at the world's most prestigious brands. From haute couture and fine watchmaking to prestige beauty, hospitality, and boutique retail, Cerulean centralises luxury employment to help you find the career for which you were destined.
Frequently Asked Questions
The luxury industry is characterised by a diverse and nuanced nomenclature. Esteemed houses frequently employ proprietary terminology, and even within a single organisation like Estée Lauder Companies, titles may vary across global markets to reflect local conventions. To ensure absolute clarity, Cerulean assigns a standardised, industry-coherent canonical title to every listing. However, it is worth noting that this role is functionally synonymous with «Validation Specialist», «Quality Assurance Manager», «Compliance Manager», «Process Validation Lead», and other variations. Our sophisticated search architecture anticipates these variations, ensuring that inquiries using related terms will seamlessly yield the exact roles you desire.