Senior Cleaning Validation Engineer

Senior Cleaning Validation Engineer United States - California - La Verne Manufacturing Operations & Supply Chain Regular · 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. Share: Job Requisition ID R0045309 Full Time/Part Time Full-Time Job Level Manager Remote Type Onsite Required Click below to return to the Gilead Careers site Click below to see a list of upcoming events Click below to return to the Kite, a Gilead company Careers site

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