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

Apply Here