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Validation Associate

Round Lk Bch, IL 60073

Posted: 11/16/2023 Employment Type: Contract Job Category: Engineering Job Number: 588941 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 30-39.33/hr **salary will be commensurate with experience 

Job Summary:

Must not be allergic to Cephalosporins or Penicillin. This position is responsible for the development and the execution of projects which include engineering studies, validation protocols and re-validations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted, and process improvements are evaluated/implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA and client/customer compliance audits.

Essential Duties and Responsibilities:
  • Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
  • Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities.
  • Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
  • Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations.
  • Review and generate quality documents including validation protocols, SOPs, change controls, and non-conformance event records as required.
  • Serves as a project lead for projects of intermediate scope with cross-functional teams.
  • Able to prioritize workload and tasks. Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.

  • Direct experience with writing and executing validation protocols is preferred.
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation.
  • Good interpersonal/communication/influencing/negotiation skills.
  • Strong project management skills
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
  • Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful.
  • Direct or indirect industry knowledge.
  • Ability to work independently or in teams.
  • Physical demands of the position may require the ability to lift materials up to 20 lbs., dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces.

Education and/or Experience:
  • BS Degree in Science, Engineering or Math with at least one or more years of experience.
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