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Sr. Validation Engineer/Quality Engineering-Cleaning Validation

Company: Kelly Services
Location: South gate
Posted on: May 3, 2021

Job Description:

Kelly Services is currently recruiting for a Direct Hire Sr. Validation Engineer/Quality Engineering position in Torrance, CA.JOB DESCRIPTIONThe Sr. Validation Engineer / Quality Engineering (QE) fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigationsJOB RESPONSIBILITIES:Conduct cleaning validation studies of production labware and equipment using UV/VIS spectrophotometry, wet chemistry, Total Organic Carbon (TOC), pH and conductivityPerform analysis of spike and recovery rinse samplesPerform mathematical calculations, interpret results and record observationsIndependently plan and execute cleaning validation studies, processes and other operationsWrite validation protocols and final reports, test methods, standard operating procedures, and technical reportsPlanning, writing and executing qualification protocols (IQ, OQ, PQ) and reportsIndependently conduct and document investigations related to validation studiesBased on validation studies, evaluate and make recommendations for improvements to operations, processes and methodsAccountable for the accuracy and validity of testing resultsSupport and assist in internal inspections and auditsPerform other related duties as assignedMake safe, efficient and conscious use of instruments, materials and other resources providedWork and communicate with different associates within the company to ensure timely completion of assigned tasks and projectsAdherence to cGMP and safety procedures and contribute to GMP systems improvementsREQUIREMENTS:Bachelors' degree in science discipline (chemistry, biochemistry, organic chemistry, biology, microbiology, chemical engineering or equivalent) requiredMinimum of 5 years of hands-on experience in cleaning validation or in a quality control analytical laboratory in a GMP/GDP environment required, and in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reportsUnderstanding and knowledgeable of cleaning validation requirements for pharmaceutical industryKnowledge of and ability to perform MAC calculation for APIsExperience with developing coupon spike and recovery studies for cleaning validationUnderstanding of test method validation per ICH Q2Experience with validation / monitoring of clean pharmaceutical utility systems, including purified water, Nitrogen systems and cold storage unitsExperience in a cGMP environment requiredExperience in an industrial chemistry laboratoryKnowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methodsGeneral lab instrumentation knowledge and operation experienceCapable of working methodically and accordingly adhering to rules and regulationsEntering or recording information in written or electronic formUsing hands and arms in handling, installing, positioning, and moving materials, and manipulating thingsBasic computer knowledge, including Microsoft Word, Excel, PowerPoint and VisioAbility to effectively organize, multitask, and work in a fast-paced, deadline driven work environmentAbility to communicate in a proactive and solution-focused manner, including keeping management aware of potential issuesDetail oriented with the ability to troubleshoot and resolve problemsAbility to work independently and manage one's timeCommunicate effectively and ability to function well in a team environment.Coach and mentor validation personnel as well as oversee the activities of contractors / vendors (as necessary)Preferred:Experience with planning and execution of cleaning validation ofproduction lab glassware and equipment including performance of validation studies, writing validation protocols and reports and other technical documents, as well as conducting validation related investigations.Experience with developing coupon spike and recovery studies for cleaning validationMaster's degree in science related field (engineering, chemistry, biology or equivalent)Experience with Qualification (IQ, OQ, PQ)Experience with Lean Six Sigma methods: Root cause analysis, failure mode analysis and analyzing / organizing complex technical problemsAPPLY NOW!For immediate consideration, please send your resume in a WORD document to gaut985@Why Kelly?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About KellyAt Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, South Gate , Sr. Validation Engineer/Quality Engineering-Cleaning Validation, Other , South gate, California

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