Cleaning Validation Engineer II
About The Position
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.
Requirements
- Understanding and application of validation principles, concepts, practices, and industry standards.
- Working knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
- Familiarity with equipment, utility systems, facility operations, and automation systems.
- Strong investigation and troubleshooting skills.
- Good verbal, written, and interpersonal communication skills.
- Proficient in Microsoft Office applications.
- Experience with recovery studies and cleaning validation within GMP-regulated environments
- Hands-on experience with swabbing execution for cleaning verification and monitoring
- Bachelor’s degree in a science or related field with at least 4 years of relevant experience OR Master’s degree (MS/MBA) with at least 2 years of relevant experience.
Responsibilities
- Perform validation activities for equipment, utilities, facilities, processes, and/or automation systems in accordance with approved SOPs, cGMPs, and regulatory requirements.
- Lead and execute cleaning validation activities for a multi‑product facility, including parenteral and solid dose products.
- Execute validation protocols and test plans, including sample collection, data recording, and results documentation.
- Compile, analyze, and interpret validation data; prepare validation reports and recommend process improvements.
- Initiate and support investigations and troubleshooting of validation deviations or failures, identifying root cause and corrective actions.
- Coordinate and execute change control activities related to validation, including drafting protocols, reports, and data summaries.
- Maintain comprehensive and compliant validation documentation and records.
- Author and revise validation procedures, protocols, and technical documentation.
- Coordinate and oversee contractors and external resources to ensure timely completion of validation activities.
- Collaborate with cross-functional teams (Manufacturing, Quality, Engineering, etc.) to support project execution.
- Provide day-to-day guidance and training to validation technicians and junior staff as needed.
- Serve as a technical resource for validation-related inquiries from internal teams, contractors, and vendors.
- Resolve moderately complex validation issues with limited supervision while ensuring compliance and data integrity.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
