Engineering Compliance & Capex Lead

As an Engineering Compliance & Capex Lead, you will be responsible for ensuring compliance and overseeing capital projects at the Jeddah site. The role will ensure adherence to current Good Manufacturing Practice (cGMP), regulatory, statutory, Environmental Health & Safety (EHS), and Good Engineering Practice (GEP) requirements, thereby minimizing risks related to supply security, compliance, people, and the environment. The role includes implementing engineering standards, managing the Corporate EHS/Engineering Alert Process, and coordinating Engineering & EHS changes (Non-GxP). Additionally, the role oversees the management of site capital projects, ensuring alignment with strategic objectives, effective risk management, and compliance. Engaging with stakeholders to develop solutions for site problems resulting in projects is also a key responsibility.

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

Key Responsibilities:

Compliance Aspects:

Engineering Standard (ES) Implementation Process

• To manage new ES and up versioned ES rollout, Gap Analysis (GA) and Risk Assessment (RA) by SME, RA Panel Review, Risk Escalation.
• Ensure the site preventative Maintenance and Calibration Program is aligned and compliant with the GSK Quality Management System

Corporate EHS/Engineering Alert

• To coordinate & drive Alert rollout to SME for Gap Analysis (GA), Risk Escalation, CAPA tracking and provide prompt update to corporate, site and department governance meeting

Non-GXP Engineering & EHS Change Control Process (NEEC)

• To be the Subject Master Expert (SME) and provide technical advice.
• To manage and control the process to comply with current Good Manufacturing Practice (cGMP), Regulatory, Statutory, Environment, Health & Safety (EHS) and Good Engineering Practice (GEP) requirements.
• To oversee new NEEC registration, closure extension. To provide monthly reporting of overdue and outstanding PMP status for governance reporting

Department Governance Meeting

• To manage, conduct and provide Quality KPI update to drive towards quality compliance, continuous improvement and meeting site SOP requirements for the monthly GMP meeting
• To manage, conduct and provide KPI update in alignment with corporate Engineering Governance Meeting for the monthly Engineering Governance Meeting

Risk Management

• To work with stakeholders to ensure risks are being identified, assessed, escalated, mitigation action item planned and follow up with timely update in Risk Management System (RMS).
• To present to site pre–Risk Management Compliance Board (pre RMCB) on new risk and mitigation plan approval, existing risk action closure or extension and mitigation plan and risk closure

GMP/EHS Lv 1 Audit process and Management of Lv2, Lv3 & Lv4 Audit

• To develop annual audit schedule & universe, rollout scheduled audit with revised checklist, monitoring of report issuance, CAPA tracking and status update at Department Governance meeting and also to Quality Services for site SQC meeting reporting.
• To coordinate site Lv1, Lv2, corporate Lv3 and Customer/Regulatory Lv4  audit for the department during audit preparation and actual audit.

Department Training Management

• To be the Subject Master Expert (SME) and provide technical advice.
• To tackle the department training related issues as the department training coordinator such as Job Description, myLearning, Delegation Matrix, outstanding & overdue SOP training, training rollout and to work with site L&D team to resolve training related issue

GPS Implementation & Continuous Improvement

• The implementation of the GSK Production System (GPS) for Engineering Services department

issues and continuous improvement initiatives.

Capex Aspects:

• Ensure compliance with Project management Framework Standards, Mandatory practices and Best Practices (as applicable) and Engineering Standards
• Oversee the management of site portfolio of capital projects, ensure alignment with the site’s strategic objectives and deliver value.
• Lead the planning, execution, and closure projects, managing risks, and ensuring compliance with relevant standards and regulations.
• Engage with stakeholders to develop solutions to identified site problems that have resulted in a project.
• Lead multi disciplined teams of project engineers, department capex representatives and support staff, making use of external consultants and contractors, to implement capital project safely, on time, to the specification, and within budget.
• Ensure Use of Site Plant and facility condition assessment to ensure fit for purposes and ready for use facilities and equipment.
• Ensure utilization of Facility Master Plan and keeping it up to date.

Why you?

Basic Qualifications:

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

• Bachelor’s degree in engineering (Mechanical / Electrical / Industrial).
• 3-5 years experience in similar role
• Experience in project planning/execution/support
• Sound understanding of a breadth of engineering standards and practices.
• Good knowledge of the appropriate GMP, Quality, EHS, Engineering standards
• Strong in influencing techniques.
• Effective demonstration of managing compliance and upholding standards in a practical environment.
• Knowledge of external institutions, authorities and benchmark organizations in engineering practice, skills development, assessment and accreditation.
• Effective demonstration of managing compliance and upholding standards in a practical environment.
• Knowledge of external institutions, authorities and benchmark organizations in engineering practice, skills development, assessment and accreditation

Closing date:

25/04/2025

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Contact information:
You may apply for this position online by selecting the Apply now button.

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