Quality Engineer - III

Santa Monica, CAContract Duration: 6-18 monthsRate: NegotiableSalary: NA $1.00Responsibilities:Excellent employment opportunity for a Quality Engineer III in the Santa Monica, CA area.We are seeking a highly motivated individual to join us as Quality Engineer III, at our location in Santa Monica.Responsible for overseeing and approving laboratory equipment validation strategies required to complete assigned validation projects.An ideal candidate would have extensive experience with the performance of such validation activities that include Equipment/Utility/Facility Qualification and Cleaning Validation across the entire validation lifecycle from Plan to Retire.Expected to make a significant contribution to a multi-disciplinary team driving adherence and consistent implementation of the Pharmaceutical Quality System across the network.Lead and/or support risk analysis activities. Demonstrate proficiency in applying various risk management and risk mitigation tools and practices such as FMEA and others.Create and maintain the site validation master plan and its periodic review program.Lead/coordinate completion of Equipment Qualification deliverables such as user requirement specifications (URS), system impact assessments (SIA), Qualification Protocols (IQ/OQ/PQ), Design Specifications, Functional Risk Assessments (FRS), etc.Ensure periodic reviews of Risk Management Reports are performed according to schedule.Support change controls and related activitiesEnsure validation and data integrity requirements are met in accordance with company proceduresProvide insight as a subject matter expert (SME) on the risks associated with analytical equipment such as chromatography, compendial analytical methods, Flow Cytometry, etc.Provide insight as a subject matter expert (SME) on the risks associated with data integrity associated with analytical equipment.Provide quality oversight of site Validation Engineering execution activities, and external partnersApply Statistical methods and Data Analytical Tool for Data Analysis.Support Equipment and laboratory life cycle processes.Experience:Master's Degree in Technical discipline (Engineering/Biology/Chemistry/Microbiology) and 3+ years of experience in a Pharmaceutical or FDA regulated environment ORBachelor's Degree in Technical discipline (Engineering/Biology/Chemistry/ Microbiology) and 5+ years of experience in a Pharmaceutical or FDA regulated environment ORHigh School Degree in Technical discipline (Engineering/Biology/Chemistry/ Microbiology) and 9+ years of experience in a Pharmaceutical or FDA regulated environmentStrong written and verbal communication skillsPreferred Qualifications:Bachelor's Degree in Engineering with a strong knowledge of Quality Engineering /Scientific Method and Techniques.Excellent technical writing experience in a Regulatory environment.Experience Equipment, Facility and Utility IQ/OQ/PQ/PVKnowledge in computer System validation in a GMP environmentStrong Knowledge of Risk Assessments and Risk Mitigation tools (e.g., FMEA).Strong Knowledge of Change Control PracticesStrong Analytical and Statistical skillsFamiliarity with global regulatory agencies' requirements for Quality Risk Management and Quality Systems (ICH Q9, GAMP5, 21CFR 11/210/211)