Sr. Cleaning Validation Engineer II

Gilead Sciences • La Verne, CA

19h

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. 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.

Requirements

• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees