Sr. Cleaning Validation Engineer II

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.

• Contributes directly to the completion of projects through the development of validation schedules, project plans, master plans, validation protocols and reports for systems that may be complex in nature to support clinical and commercial manufacturing.
• Works independently to resolve moderately complex to complex validation issues with very limited direct supervision.
• Conducts and serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations related to distribution and validation activities.
• Provides technical assessment and approval for engineering and process changes.
• Forecast external support requirements for continuous validation support, including implementation of new projects.
• Coordinates the activities of assigned validation and contract personnel, ensuring the quality of completed work.
• Prepares regulatory submissions and presents validations to regulatory authorities during routine internal and pre-approval inspections.
• Provides relevant CMC support for pre- and post-approval filings.
• Leads standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Systems.
• Works with Quality to adopt an effective quality management system and achieve the quality objectives.
• Implements new technologies, programs or initiatives.
• Provides leadership for the Validation team and ensures growth and development of staff to meet changing business needs.

• Knowledgeable of the principles of GxPs.
• Expertise in aseptic manufacturing principles, including production of complex injectable formulations, contamination control, cleaning validation and isolator technology.
• Injectable product experience (biologics or pharmaceutical) required.
• Must have in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Demonstrate extensive knowledge of industry best practices and trends.
• Ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• Ability to develop solutions to complex problems requiring ingenuity, creativity and innovation.
• Ability to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Excellent verbal, written, and interpersonal communication skills.
• Demonstrate ability in managing competing priorities and creating an effective team environment.
• Bachelor’s degree in science or engineering (minimum eight (8) years of experience) or Master’s degree with minimum six (6) years of experience.

The salary range for this position is: $ - $. This role may also be eligible for discretionary annual bonus, stock‑based long‑term incentives, paid time off, and a comprehensive benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit Gilead Compensation & Benefits.

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 are made without discrimination based on protected characteristics in accordance with applicable laws.