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Cleaning Validation Engineer II

米国 - カリフォルニア - ラバーン正社員

仕事内容

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

Knowledge & Skills:

  • 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.

Key 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.
  • Experience with recovery studies and cleaning validation within GMP-regulated environments
  • Hands-on experience with swabbing execution for cleaning verification and monitoring
  • Occasionally support night, weekend, and off-shift schedules as needed based on business demands

Basic Qualifications:

  • 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.


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.


For jobs in the United States:

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.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT


Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.