Validation Lead

12395 Haleon US Inc.; Lincoln (NE); Vor Ort; USD 110.000 - 135.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Tuition reimbursement

Paid parental leave (6 months)

Zusammenfassung

Haleon, a leading consumer health company, is seeking an experienced Site Validation Lead for our Lincoln, NE site. You will oversee validation activities across departments to ensure regulatory compliance and audit readiness, while developing the technical team.

Ideal candidates have a BS in engineering or a scientific field and 5+ years in FDA-regulated environments with cleaning validation expertise. This onsite role offers a comprehensive benefits package and opportunities for career growth.

Qualifikationen

• BS degree in engineering, industrial pharmacy, chemistry, or similar scientific discipline.
• 5+ years of FDA-regulated technical experience, with strong cleaning validation background.
• Excellent communication and cross-functional collaboration skills.

Aufgaben

• Oversee and manage all site validation activities to ensure regulatory and Haleon standards.
• Lead cross-departmental efforts to execute validation processes and maintain audit readiness.
• Develop the technical team and ensure cleaning validation practices yield compliant results.
• Collaborate with Engineering, Quality and Technical teams to complete validations on time.
• Demonstrate system compliance to regulatory auditors (FDA, Health Canada, ANVISA).
• Maintain the site validation master plan (SVMP).
• Maintain the site cleaning lifecycle process and monitor changes to ensure validated state.

Kenntnisse

Effective communication

Ausbildung

Bachelor's degree in engineering or scientific discipline

Jobbeschreibung

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

Job Posting

Oversee and manage all site validation activities, ensuring compliance with regulatory and Haleon standards. This role leads cross‑departmental efforts to execute validation processes and maintain audit readiness, while developing the technical team and ensuring cleaning validation practices yield reliable, compliant results. This role will provide YOU the opportunity to lead key activities to progress YOUR career.

These responsibilities include some of the following:

• Manages a team of Product and Process Engineers to support Product Lifecycle Management of products manufactured on site
• Accountable for oversight, management, and delivery of all Validation Lifecycle components
• Understands and ensures compliance to evolving expectations of: Equipment and Facility C&Q, Process/Packaging validation, cleaning validation, Continued Process validation (CPV), Analytical Method validation, and Computer System validation
• Collaborates across Engineering, Quality and Technical departments to ensure validation activities are completed on time and compliant to Haleon standards
• Ensures that the site can demonstrate system compliance to a regulatory auditor, (e.g., FDA, Health Canada, or ANVISA)
• Maintains site validation master plan (SVMP)
• As the site cleaning SME, maintains the site cleaning lifecycle process by assessing impact of new products, processes, or changes against the existing site cleaning matrix.
• Coaches and develops the Technical team to ensure that cleaning validation execution demonstrates that the process produces the expected results in a reproducible manner, and that proper monitoring is in place to ensure the processes remain in a validated state of control

This role is located onsite at our Lincoln, NE facility.

Why you?

Basic Qualifications:

• BS degree in engineering, industrial pharmacy, chemistry, or other appropriate scientific or pharmaceutical discipline
• 5+ years of demonstrated experience in an FDA regulated technical role, with strong experience in cleaning validation

Preferred Qualifications:

• Able to effectively communicate and work with co-workers, management, and other departments

Benefits

• Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family.
• We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.

Job Posting End Date 2026-11-23

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong. During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.