Engineering Operations Lead

We are seeking a highly skilled Engineering Operations Lead to join our team. As a key member of our organization, you will be responsible for ensuring compliance and overseeing capital projects at our site.

• Compliance Management:
  • To manage new engineering standards and ensure alignment with current Good Manufacturing Practice (cGMP), regulatory, statutory, Environmental Health & Safety (EHS), and Good Engineering Practice (GEP) requirements.
  • Ensure the site preventative Maintenance and Calibration Program is compliant with the Quality Management System.
• CORPORATE EHS/ENGINEERING ALERT PROCESS MANAGEMENT:
  • To coordinate and drive Alert rollout to Subject Matter Experts (SMEs) for Gap Analysis (GA), Risk Escalation, CAPA tracking, and provide prompt updates to corporate, site, and department governance meetings.
• NON-GXN ENGINEERING & EHS CHANGE CONTROL PROCESS (NEEC) MANAGEMENT:
  • To provide technical advice as a Subject Master Expert (SME).
  • 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, and provide monthly reporting of overdue and outstanding Project Management Plan (PMP) status for governance reporting.
• DEPARTMENT GOVERNANCE MEETING MANAGEMENT:
  • To manage, conduct, and provide Quality KPI updates to drive towards quality compliance, continuous improvement, and meeting site SOP requirements for the monthly GMP meeting.
  • To manage, conduct, and provide KPI updates 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 items planned, and follow up with timely updates in the 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 an annual audit schedule & universe, rollout scheduled audits with revised checklists, monitor report issuance, CAPA tracking, and status updates at Department Governance meetings, and also to Quality Services for site SQC meeting reporting.
  • To coordinate site Lv1, Lv2, corporate Lv3, and Customer/Regulatory Lv4 audits for the department during audit preparation and actual audits.
• DEPARTMENT TRAINING MANAGEMENT:
  • To be the Subject Master Expert (SME) and provide technical advice.
  • To tackle department training-related issues as the department training coordinator, such as Job Description, myLearning, Delegation Matrix, outstanding & overdue SOP training, training rollout, and work with site L&D teams to resolve training-related issues.
• GPS IMPLEMENTATION & CONTINUOUS IMPROVEMENT:
  • The implementation of the GSK Production System (GPS) for Engineering Services department issues and continuous improvement initiatives.
• CAPITAL PROJECTS MANAGEMENT:
  • 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 of 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 projects safely, on time, to specification, and within budget.
  • Ensure utilization 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.