Validation Engineer At GSK Egypt


Validation Engineer At GSK Egypt
Validation Engineer At GSK Egypt



Location: Giza, Egypt

Job description

Site Name: Egypt – Giza – Giza
Posted Date: Feb 18 2024
Are you looking for an opportunity to manage equipment validation for a manufacturing production line in accordance with GSK policies?  If so, this is the role for you.


As a Validation Engineer you will be responsible for executing the validation life cycle within GSK systems and departments to ensure GXP systems are in a complying validated state


This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:


  • 1- Executing the Validation Lifecycle for all new and existing GxP systems according to QMS
  • Determine the impact of the equipment/system on GMP processes through Compliance Determination  Create and execute validation lifecycle documentation such as (MBP,PRA,CD,URS,DQ,IQ,OQ,PQ,VSR) as per CSQMS, AEQMS, ITQMS depending on the type of system.
  • Verify the Validation of excel sheets & Validate excel sheets (If necessary)  Perform Periodic Validation Review to maintain and review the validated status of the systems.
  • Decommissioning of GxP systems and Excel Sheets.
  • 2- Responsible for planning and prioritizing the validation activities through the Validation Master Plan.

  • Maintain and review Site System register to ensure all mandatory fields are entered and the systems are accurately recorded.
  • Reflect the outcome of (SSL) site system list into (VMP) validation master plan
  • 3- Participate/coordinate the execution of validation testing with other departments and suppliers
  • 4- Confirming DI requirements are met in the design of new and existing system against ITMS , QMS &SOPs.
  • Management of data backups system passwords.
  • Managements of users and administrative functions for the different systems.
  • 5- Responsible for the continuous improvement and standardization of the validation activities/documentation  Maintaining a robust documentation and archival system
  • Maintain an inspection ready status ahead of any internal and external audits for validation activities
  • 6- Supporting the validation capability of the site:
  • Delivering of periodic validation training for all site staff 7- Other Quality Activities:
  • Attend all validation-related CoPs (Community of Practices) in their area of expertise.
  • Ensure that GMP principles are applied to guarantee quality of supplied products when it comes to validation activities
  • Perform Management Monitoring audits for validation department.
  • Participate in the gap analysis on relevant QMS policies, identify gaps between in-place and in use.
  • Support in sterile capability improvement program.  Participate in any investigations related to validation activities.
  • Attend all change control panels & any other meetings representing validation department in their area of expertise.



Why you?

Basic Qualifications:


We are looking for professionals with these required skills to achieve our goals:

  • Bachelors Degree in Engineering, Pharmacy or Sciences
  • 2-4 years of experience as Validation Engineer.
  • Knowledge of Equipment design, Equipment validation and sterile filling operation requirements.

Preferred Qualifications:


If you have the following characteristics, it would be a plus:

  • Good planning and coordination, problem solving and time management skills. Strong Analytical Skills & Team Work
  • Good interpersonal and communications skills.
  • Ability to work under stress and to manage conflicting priorities.
  • Production Knowledge & Experience in sterile operations is a plus.
  • Excellent command of English language


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