Validation Engineer

4 weeks ago


Tucson, United States Planet Pharma Full time

The Validation Engineer will be responsible to ensure that validation requirements are met for all existing and new equipment/ facilities/utilities and processes by preparing and executing detailed validation protocols that meet the relevant testing standards and any requirements.


Responsibilities:

  • Designs and drafts validation sampling and testing plan/protocols.
  • Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies.
  • Resolve technical issues encountered during study execution.
  • Track and expedite the review and sign-off of qualification documentation.
  • Support execution of validation activities.
  • Interact with individuals from different departments to plan, execute, and complete qualification activities.
  • Drive the completion of validation efforts according to deadlines.
  • Write / guide the writing of departmental procedures required for validation.
  • Assist during internal and 3rd party audits wrt validation requirements.
  • Initiate CAPAs, NCRs and Change Requests where required and assist with investigations.
  • Assist with identifying maintenance and calibration requirements.
  • Coordinate suppliers wrt Validation activities including obtaining quotes from suppliers.
  • Validation administration such as updating the validation plan, maintaining databases, standard referencing of documentation.
  • Review Validation plans, protocols and SOPs written by other validation team members.
  • Manage workload arising from unscheduled events.
  • Other duties as assigned by management.


QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.


Pay Rate: $34-40/Hr *Salary will be commensurate with candidate experience


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