Validation Engineer

3 weeks ago

مصر, Egypt GSK Full time

**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 DeterminationCreate 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/documentationMaintaining 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

**Why Us?**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

**Contact information**:
**Important notice to Employment businesses/ Agencies

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