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.

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Job Requisition  R0045309

Full Time/Part Time Full-Time

Job Level Manager

Remote Type Onsite Required

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