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Validation Engineer Sterile Injectables

 

Validation Associate

We have a range of openings available for all levels of Validation Associates with a Sterile Injectables background. Candidates must have background working in a GMP Pharmaceutical environment and have experience working within an Steriles group. An Engineering degree and background is preferred, but other scientific education will be considered as well. Main job duties will include writing and analyzing technical reports and validation reports, as well as working closely with the groups in the production of the plant. 

 

  • Prepare, review and approve validation, hold, investigation and audit reports; gain multidisciplinary consensus; make recommendations to management based on review and analysis of data. 
  • Manage, schedule, execute and track multiple project activities of moderate complexity with multi-disciplinary departments to ensure timely completion of deliverables.
  • Analyze data to determine trends, acceptability, identify deviations and assure resolution of deviations.
  • Conduct deviation investigations, such as validation failures, complaints and hold investigations. Identify appropriate corrective actions.
  • Assess impact of changes in systems, critical documentation, processes and suppliers.
  • Identify critical parameters/processes and takes appropriate actions to ensure adequate controls are in place.
  • Interact during client and regulatory audits.
  • Lead audits and/or assist with regulatory audits.
  • Provide training in area of expertise within Validation.
  • It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace.
  • Comply with all job-related safety and other training requirements.

Experience with some or all of the following:

  • Autoclaves
  • Cappers
  • Automated Fillers
  • Tank Cleaners
  • Commercial Fillers
  • Temperature Mapping
  • Kaye Validators
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