Senior Cleaning Validation Engineer

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
 

Sr. Cleaning Validation Engineer

Job Responsibilities:

· Serve as the Cleaning Validation lead of cross functional team and able to provide guidance during planning, designing and development of projects.

· Write and review technical documentation (cleaning cycle development reports, SOPs, system lifecycle documentation, protocols & reports for engineering and validation testing, cleaning validation master plans)

· Creation, execution of Cleaning Validation Protocols, including identification and resolution of non-conformances/deviations.

· Assist in preparation of regulatory submissions and presents validation in respective SME areas to regulatory authorities during regulatory inspections.

· Manage contractors performing system qualifications, ensure the quality of completed deliverables.

· Report status and progress of qualification activities or projects to the Leadership team.

Knowledge & Skills:

· Demonstrated knowledge of cleaning validation principles, methodology and life-cycle associated practices.

· Proven experience and expertise in executing cleaning studies for biological products.

· Experience with cleaning validation programs in multi-product facilities, including biological products, complex small molecule formulations, potent and non-potent products.

· Demonstrated ability to use a risk-based approach for defining cleaning validation approach for new products.

· Demonstrated knowledge of biopharmaceutical manufacturing including drug product formulation and fill/finish operations.

· Experience with automated cleaning processes (CIP and parts washers) as well as manual cleaning and sanitization operations.

· Experience with qualification of automated cleaning processes and oversight of cleaning cycle development activities.

Education & Experience:

· A Bachelor’s Degree in Science, Engineering or a related field with a minimum of seven (7) years of relevant experience OR Master's Degree in Science, Engineering or a related field with a minimum of four (4) years of relevant experience.

· Knowledge of the cleaning validation role inside of a cGMP manufacturing environment.

· Experience working with the regulations and requirements for biologics or pharmaceuticals.

· Knowledge of scientific and engineering principles in the biopharmaceutical industry.

· Proven track record to create, review, and execute qualification protocols and associated validation lifecycle documentation, including identification and resolution of non-conformances /deviations.

· Automated equipment and system qualification experience in a cGMP environment for process and manufacturing equipment and systems.

· Knowledge and experience with life-cycle approach to cleaning validation in multi-product facility.

 

The salary range for this position is: $123,930.00 - $160,380.00. 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*.

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