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Manufacturing Validation Engineer

Yugady Technologies San Francisco Contractor
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Job title: Manufacturing Validation Engineer

Location: Houston, TX

Duration: 1+ year

The Manufacturing Validation Engineer provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and quality requirements.

Essential Functions:

  • Assist in the preparation/ execution IQ/OQ/PQ protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor.
  • Performs re-qualification of equipment, facility and utilities as required under supervision.
  • Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution.
  • Draft SOP for new operational equipment.
  • Execute process validation and support validation testing by analyzing equipment qualification parameter ranges and challenge tests criteria to technical service.
  • Works with equipment vendors to collect equipment functional specifications, manual and other required documents.
  • Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement.

Additional Responsibilities:

  • Assists with validation projects and performs other system validation duties as assigned.

Education:

  • Master Degree (MS/MA) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Preferred

Experience:

  • Manufacturing Validation Testing in Pharmaceutical Industry, cGMP environment

  • Ability to work both independently and in conjunction with a team - Advanced

 

 

Harsha  K, Sr.Recruiter 

LiveMindz

harsha@livemindz.com

 

Skills required

Engineering
Manufacturing
Compliance Reports
Product Quality Assurance
Operations
Technical Services
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