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Cleaning Validation Associate

Company: Renaissance Pharmaceuticals
Location: Lakewood
Posted on: August 2, 2019

Job Description:

Overview

This position is responsible for supporting the Cleaning Validation program requirements (i.e. included but not limited to equipment processes and procedures that support commercial and new R&D drug development activities for Renaissance, for all delivery systems manufactured in the Lakewood, NJ plant). This position is also responsible for generating and executing validation protocols and providing written reports.

Responsibilities

  • Develop validation protocols (i.e. development, qualification, validation and monitoring), execute and/or coordinate the execution of protocols / forms (i.e. verification) and review / compilation of data to form a final report (where applicable).

    • Review of Master Batch Records. Ensure the content of the batch records meet the validated state of the process.

      • Develop Design of Experiments (DOEs), develop statistical sampling plans, assess and approve quality attribute requirements, as well as performing statistical analysis and evaluation of data to draw technical conclusions and make decisions.

        • Perform validation activities within an aseptic and sanitary pharmaceutical environment.

          • Provide technical assistance for investigations into process / product issues in support of the validation deviations and review of design requirements for products and or equipment.

            • Maintain updates to all Cleaning Validation databases (i.e. Cleaning Validation Master Spreadsheet, Cleaning Validation Matrix, Surface Area Database, LD50 Database, and Equipment Tracking Database).

              • Time management skills are a must. Effectively meet all timelines that are given for projects assigned.

                • Interfaces with other departments in support of validation activities.

                  • Additional duties as assigned.

                    Qualifications

                    Bachelor's Degree (BA or BS) in a Science, Engineering or other related field required.SAMPLE JD TEXT: Bachelor's Degree in related field required with a minimum of ## years of relevant experience in the pharmaceutical industry or equivalent combination of education and experience. Master's Degree preferred.

                    Entry level - no experience required. Prefer at least 2 years of relevant experience in the pharmaceutical industry, preferably in a sterile manufacturing environment. PI112393937

Keywords: Renaissance Pharmaceuticals, Lakewood , Cleaning Validation Associate, Other , Lakewood, New Jersey

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