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Validation Engineer Oral Solid Dose

Validation Engineer

We have a range of openings available for all levels of Validation Associates with a Oral Solid Dose background. Candidates must have background working in a GMP Pharmaceutical environment and have experience working within an oral solid dosage 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 equipment listed

  • Autoclaves
  • Cappers
  • Automated Fillers
  • Tank Cleaning
  • Commercial Fillers
  • Temperature Mapping
  • Kaye Validator

 

 

 

 

 

 

 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

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