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Validation Engineer

GSK
Cairo, Egypt
Posted 5 years ago
39People have clicked1 open position
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Job Details

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Job Description

Your Responsibilities:

Job Purpose

  • Represent the validation activities within the Validation Working Parties and generate the required validation documentation and execute/witness validation activities

Key Accountabilities/Responsibilities

  • Participate in different validation working parties for organizing the different validation activities for process equipment and utilities upgrades.
  • Ensure that all validation activities and documentation are complying with the mandated QMS requirements under direct supervision of Validation Section Head.
  • Prepare Design Review (DR), installation/operational qualification (IQ/OQ), performance qualifications (PQ), protocols and validation reports (VR) for different validation activities for process equipment and utilities upgrade in accordance to VLC and CSV equipment.
  • Participate in execution of qualification testing with different departments.
  • Follow up, with different departments and external suppliers, completion and review of the required qualification testing documents.
  • Support the implementation of company safety rules.
  • Report validation KPI’s to Section Head. Prepare validation review protocols, conduct review activities and prepare validation review reports for process equipment and utilities.
  • Prepare decommissioning protocols, conduct and coordinate related activities and prepare decommissioning reports for process equipment and utilities.
  • Attend change control panels relevant to process equipment and utilities upgrades and de-commissioning.
  • Participate in preparation of risk assessments for process equipment and utilities.
  • Support GPS implementation for managing Validation different activities.
  • Responsible for performing validation maintenance / review through preparing protocols, collecting evidences and reporting to section head.

Job Requirements

Why You?
Basic qualifications:

  • Bachelor degree of Engineering
  • Minimum 2 years experience in a similar position, preferably in pharmaceutical company.
  • Good background of Pharmaceutical manufacturing requirements.
  • Good background of GLP, GMP and GEP requirements.
  • Good experience of Calibration.
  • Good knowledge in HVAC, control and Sensors technologies.
  • Good command of English language and Computer skills.
  • Good communication and organization skills.
  • Good computer skills.

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