Validation Engineer I in Hillsboro, OR at Apex Life Sciences

Date Posted: 9/15/2018

Job Snapshot

Job Description


Duties: 

  • Application of basic Engineering/Scientific and GMP theories, principals and technical.
  • Basic understanding of biopharmaceutical processes, equipment and facilities.
  • Familiarity with Roche Quality systems and processes.
  • Understanding of cGMP regulations and some knowledge of broader regulatory policies, guidelines and requirements, and ability to apply understanding under guided situations
  • General understanding of computer systems and programs (MS Office).
  • General understanding of documentation control databases (EDMS); laboratory databases (LIMS), inventory management (SAP).
  • General knowledge of control systems and automation systems (DeltaV, MES, data historians)
  • Good technical writing skills.

Skills: 

  • Support the development, execution, and management of the detailed project plans and timelines for the execution of PQ/CV/PV/RV activities.
  • Coordinate the collection, testing and analysis of samples and reporting of results required per validation protocol.
  • Prepare technical documents, including protocols, summary reports, etc., for validation activities.
  • Provide support and input into validation deviations including root cause analysis and corrective actions.

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 844-463-6178.




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