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Validation Engineer I

Company: Renaissance LLC
Location: Lakewood
Posted on: June 17, 2022

Job Description:

Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.OverviewThis position is responsible for duties associated with qualifying manufacturing and packaging (primary and secondary) equipment, other supplementary equipment including laboratory equipment, storage areas (temperature & humidity mapping), and pharmaceutical utilities, including but not limited to HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and compressed gases consistent with cGMP requirements for clinical manufacturing, scale-up and commercial manufacture of sterile and specialty pharmaceutical products. Major job functions include: generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, managing project timelines, and participating in cross functional team activities. Responsibilities

  • Responsible for the validation studies required for qualifying manufacturing and packaging (primary and secondary) equipment, other supplementary equipment including laboratory equipment, storage areas (temperature & humidity mapping), and pharmaceutical utilities, including but not limited to HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and compressed gases.
  • Collect and tabulate laboratory data, review laboratory data for errors and discrepancies, and transcribe results into final reports.
  • Generate, review and approve qualification/validation procedures.
  • Generate final reports, compile historical data packages, and route documents for approval.
  • Review and approve set-up and operation procedures for production and packaging equipment.
  • Generate risk assessments to discuss the approach to qualification related activities.
  • Support the rationale for the sample size selection during process equipment qualification.
  • Review and complete assigned Change Control tasks. Qualifications
    • Bachelor's Degree in Engineering, Life Sciences or related discipline, Prefer at least 2 years of relevant experience in the pharmaceutical industry
    • Minimum of 2 years of relevant experience performing validation activities within pharmaceutical environment; or equivalent combination of education and experience.
      • Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.
      • Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.PI180170285

Keywords: Renaissance LLC, Lakewood , Validation Engineer I, Other , Lakewood, New Jersey

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