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Sr. Validation Engineer/Quality Engineering-Cleaning Validation

Company: Kelly
Location: South Gate
Posted on: April 30, 2021

Job Description:

Kelly Services is currently recruiting for a Direct Hire Sr. Validation Engineer/Quality Engineering position in Torrance, CA. JOB DESCRIPTION The 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 investigations JOB RESPONSIBILITIES:

  • Conduct cleaning validation studies of production labware and equipment using UV/VIS spectrophotometry, wet chemistry, Total Organic Carbon (TOC), pH and conductivity
  • Perform analysis of spike and recovery rinse samples
  • Perform mathematical calculations, interpret results and record observations
  • Independently plan and execute cleaning validation studies, processes and other operations
  • Write validation protocols and final reports, test methods, standard operating procedures, and technical reports
  • Planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
  • Independently conduct and document investigations related to validation studies
  • Based on validation studies, evaluate and make recommendations for improvements to operations, processes and methods
  • Accountable for the accuracy and validity of testing results
  • Support and assist in internal inspections and audits
  • Perform other related duties as assigned
  • Make safe, efficient and conscious use of instruments, materials and other resources provided
  • Work and communicate with different associates within the company to ensure timely completion of assigned tasks and projects
  • Adherence to cGMP and safety procedures and contribute to GMP systems improvements REQUIREMENTS:
    • Bachelors' degree in science discipline (chemistry, biochemistry, organic chemistry, biology, microbiology, chemical engineering or equivalent) required
    • Minimum 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 reports
    • Understanding and knowledgeable of cleaning validation requirements for pharmaceutical industry
    • Knowledge of and ability to perform MAC calculation for APIs
    • Experience with developing coupon spike and recovery studies for cleaning validation
    • Understanding of test method validation per ICH Q2
    • Experience with validation / monitoring of clean pharmaceutical utility systems, including purified water, Nitrogen systems and cold storage units
    • Experience in a cGMP environment required
    • Experience in an industrial chemistry laboratory
    • Knowledge 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 methods
    • General lab instrumentation knowledge and operation experience
    • Capable of working methodically and accordingly adhering to rules and regulations
    • Entering or recording information in written or electronic form
    • Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things
    • Basic computer knowledge, including Microsoft Word, Excel, PowerPoint and Visio
    • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
    • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
    • Detail oriented with the ability to troubleshoot and resolve problems
    • Ability to work independently and manage one's time
    • Communicate 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 of production 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 validation
      • Master'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 problems APPLY NOW! For immediate consideration, please send your resume in a WORD document to 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 Kelly -- At 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, South Gate , Sr. Validation Engineer/Quality Engineering-Cleaning Validation, Engineering , South Gate, California

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