Sr. 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.
 

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:

• 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.

• Work with Quality to adopt an effective quality management system and achieve the quality objectives.
• Able to implement new technologies, programs or initiatives.

• Provide leadership for Validation team and ensure growth and development of staff to meet changing business needs.

Basic Qualifications:

• 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.

• Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.

• Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovation.

• Able to exercise judgment and independently determine and take appropriate action where precedent may not exist.

• Excellent verbal, written, and interpersonal communications skills are required.
• Demonstrate ability in managing competing priorities, creating an effective team environment.
• A bachelor’s degree in science, engineering or a related field with a minimum of eight (8) years of relevant experience or master’s degree in science, Engineering or a related field with a minimum of six (6) years of relevant experience.

 

The salary range for this position is: $143,225.00 - $185,350.00. 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.