Validation Engineer II

Company Name: Gilead Sciences

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Key Responsibilities

• Contribute to validation projects by developing schedules, master plans, impact assessments, risk assessments, validation protocols, reports, and requirements trace matrices for complex systems supporting clinical and commercial manufacturing.
• Perform Computer System Validation (CSV) elements for equipment, utility systems, facilities, processes, and automation systems.
• Author validation master plans, risk assessment documents, protocols, technical reports, and requirement trace matrices.
• Embed data integrity principles into daily operations and validation programs.
• Coordinate validation activities with cross-functional teams to ensure timely and budget-conscious execution.
• Foster collaborative relationships across teams to deliver high-performance validation programs.
• Identify and drive continuous improvement initiatives for compliant and lean sustainable solutions.
• Review project-related documents and data from vendors, validation teams, and project teams.
• Represent the validation department on cross-functional project teams.

Basic Qualifications

• Bachelor’s degree in science or a related field with 4+ years of relevant experience, OR
• Master’s degree (MS or MBA) with 2+ years of relevant experience.
• Understanding and application of validation principles, including GAMP, Part 11, Data Integrity, and Annex 11.
• Proficiency in current Good Manufacturing Practices (GMPs).
• Working knowledge of equipment, systems, and industry practices.
• Strong verbal, technical writing, and interpersonal communication skills.
• Ability to resolve moderately complex validation issues with limited supervision.
• Proficiency in Microsoft Office applications.

Preferred Qualifications

• Experience using Root Cause Analysis tools.
• Operational excellence mindset and experience driving continuous improvement initiatives.
• Experience coordinating cross-functional validation projects.

The salary range for this position is: $99,705.00 - $129,030.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For Additional Benefits Information, Visit

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees And Contractors

Please apply via the Internal Career Opportunities portal in Workday.