Validation Engineer-Assay Validation

1 month ago


Thousand Oaks, United States Oxford Global Resources Full time

Essential Skills and Experience:

  • Experience in reviewing and approving validation documents (test plans, protocols, reports, etc.) to ensure compliance with internal procedures and regulatory requirements.
  • Ability to make validation documents understandable and defendable during inspections.
  • Experience in supporting site project validation activities and ensuring all cGMP regulatory requirements are met.
  • Familiarity with method verification protocols, SOP and worksheet, execution of protocols, and methods reports.
  • Experience with Bio burden, Endotoxin, Growth Promotion, Identification, Identity – HPLC, ID-Osmolality, Material Appearance, Osmolality, Solubility, Sterility.
  • Experience in validating assays.
  • Knowledge of the current ISPE Baseline Guidelines for Commissioning and Qualification and GAMP5.
  • Experience in drafting validation protocols and reports.

Desirable Skills and Experience:

  • Experience with Kneat and Paperless Validation Software. (Plus)
  • Experience Drafting Validation Protocols and Reports (MUST)
  • Experience with Assay's (MUST)



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