Validation Lead

Haleon • Lincoln, NE

10d • Onsite

About The Position

The Validation Lead oversees and manages all site validation activities, ensuring compliance with regulatory requirements and Haleon standards. The role leads cross-departmental validation efforts, maintains audit readiness, manages the site validation master plan, and develops the technical team. As the site cleaning subject matter expert, the Validation Lead oversees cleaning validation practices and helps ensure processes deliver reliable, compliant, reproducible results and remain in a validated state of control. The position is located onsite at Haleon’s Lincoln, Nebraska facility.

Requirements

• Bachelor of Science degree in engineering, industrial pharmacy, chemistry, or another appropriate scientific or pharmaceutical discipline.
• At least 5 years of demonstrated experience in an FDA-regulated technical role.
• Strong experience in cleaning validation.

Nice To Haves

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

Responsibilities

• Manage a team of Product and Process Engineers supporting Product Lifecycle Management for products manufactured at the site.
• Oversee, manage, and deliver all components of the Validation Lifecycle.
• Understand and ensure compliance with evolving expectations for Equipment and Facility C&Q, Process/Packaging validation, cleaning validation, Continued Process Validation (CPV), Analytical Method validation, and Computer System validation.
• Collaborate across Engineering, Quality, and Technical departments to complete validation activities on time and in compliance with Haleon standards.
• Ensure the site can demonstrate system compliance to regulatory auditors, including those from the FDA, Health Canada, or ANVISA.
• Maintain the site validation master plan (SVMP).
• Maintain the site cleaning lifecycle process as the site cleaning subject matter expert, assessing the impact of new products, processes, or changes against the existing site cleaning matrix.
• Coach and develop the Technical team to ensure cleaning validation execution demonstrates reproducible expected results and includes appropriate monitoring to keep processes in a validated state of control.

Benefits

• Competitive pay.
• Generous 401(k) plan.
• Tuition reimbursement.
• Time-off programs, including 6 months of paid parental leave.
• Benefits eligibility on day one, including healthcare programs for which the company pays the majority of medical coverage for employees and their families.
• Opportunity to receive a discretionary bonus based on achievement of key business performance.
• Other incentive and recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior