Validation Lead

GSK • Lincoln, NE

8d • 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 execution of validation processes and helps maintain audit readiness, while developing the technical team and ensuring cleaning validation practices produce reliable, compliant results.

The position manages Product and Process Engineers supporting product lifecycle management for products manufactured on site and is accountable for oversight, management, and delivery of all validation lifecycle components. It works with Engineering, Quality, and Technical departments to complete validation activities on time and in compliance with Haleon standards. The role is based 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 and work effectively with co-workers, management, and other departments.

Responsibilities

• Manage a team of Product and Process Engineers supporting product lifecycle management for products manufactured on site.
• Oversee, manage, and deliver all validation lifecycle components.
• Ensure compliance with evolving expectations for equipment and facility commissioning and qualification (C&Q), process and packaging validation, cleaning validation, continued process validation (CPV), analytical method validation, and computer system validation.
• Collaborate with 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, such as the FDA, Health Canada, or ANVISA.
• Maintain the site validation master plan (SVMP).
• As the site cleaning subject matter expert, maintain the site cleaning lifecycle process by 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 that appropriate monitoring keeps processes in a validated state of control.

Benefits

• Competitive pay
• Generous 401(k) plan
• Tuition reimbursement
• Time-off programs
• Six months of paid parental leave
• Healthcare programs, with the company paying the majority of medical coverage for the employee and family
• Opportunity to receive a discretionary bonus based on key business performance
• Other incentive and recognition programs

What This Job Offers

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