Position Summary 

The Senior MES Sustaining Engineer is responsible for the lifecycle management, support, continuous improvement and compliance of Manufacturing Execution System (MES) solutions supporting commercial manufacturing operations. The role ensures reliable MES performance, supports manufacturing operations, drives process improvements, and delivers compliant digital solutions in a cGMP-regulated environment. 

• The successful candidate will collaborate with Manufacturing, Quality, Automation, Validation, IT and Engineering teams to maintain and enhance MES solutions while ensuring operational excellence, compliance and business continuity. 

Key Responsibilities 

MES Operations & Support 

• Provide technical ownership and support for Syncade MES and associated manufacturing systems. 

• Lead investigation and resolution of MES incidents, deviations and production support issues. 

• Ensure system availability, reliability, and performance to support manufacturing operations. 

• Support Front Line Support (FLS) teams and provide SME guidance when escalation is required. 

• Participate in on-call and operational support activities as needed. 

Continuous Improvement 

• Identify, evaluate and implement MES process improvements that increase efficiency, compliance, and user experience. 

• Drive digitalization initiatives and automation opportunities within manufacturing operations. 

• Utilize data-driven decision-making and structured problem-solving techniques to improve business outcomes. 

• Support lean manufacturing initiatives and continuous improvement programs. 

Project & Change Management 

• Support implementation of MES enhancements, new product introductions (NPI), and site automation projects. 

• Manage and execute MES change controls, risk assessments, impact assessments, testing, and deployment activities. 

• Partner with project teams to ensure solutions align with business requirements and site standards. 

Compliance & Quality 

• Ensure compliance with cGMP, GxP, data integrity, cybersecurity, and internal quality requirements. 

• Support audits, inspections, and periodic reviews. 

• Develop and maintain system documentation, SOPs, work instructions, and technical specifications. 

• Assist with validation of deliverables including IQ/OQ/PQ and computerized system validation documentation. 

Collaboration & Stakeholder Management 

• Collaborate effectively with Manufacturing, QA, Validation, Automation, Supply Chain, and IT stakeholders. 

• Communicate technical solutions clearly to both technical and non-technical audiences. 

• Influence and drive alignment across cross-functional teams. 

• Engage with external vendors and service providers when required. 

Mentoring & Leadership 

• Provide technical coaching and mentorship to junior engineers and support teams. 

• Share knowledge and best practices across the MES organization. 

• Support development of standards and sustainable support models. 

Required Qualificationsns 

Education 

• Bachelor's degree in engineering, Computer Science, Automation, Biotechnology, Pharmaceutical Sciences, or related discipline. 

Experience 

• Significant experience supporting Manufacturing Execution Systems within a pharmaceutical or biotechnology environment. 

• Experience with Syncade, PAS-X or equivalent MES platforms. 

• Experience working in regulated GxP environments. 

• Proven experience with manufacturing support, troubleshooting, and continuous improvement initiatives. 

Technical Skills 

• Strong knowledge of MES architecture and manufacturing processes. 

• Understanding automation systems including DCS, PLC, SCADA, and system integrations. 

• Knowledge of ISA-88 batch concepts and manufacturing workflows. 

• Experience with change management, validation, and quality systems. 

• Understanding cybersecurity and computerized system lifecycle management. 

Core Competencies

Business Skills 

• Critical and Strategic Thinking 

• Results & Execution Focus 

• Digital Fluency & Stewardship 

• Communication, Collaboration & Influence 

People Skills 

• Adaptability & Change Orientation 

• Leading Self and Mentoring Others 

Technical Skills 

• Lean Mindset 

• GxP, Safety & Regulatory Compliance 

• Automation Technical Knowledge 

• Supplier Interface Management 

Success Measures 

• The successful candidate will: 

• Ensure stable and compliant MES operations. 

• Deliver measurable improvements to manufacturing processes and digital systems. 

• Effectively support manufacturing operations through rapid issue resolution. 

• Drive continuous improvement initiatives. 

• Demonstrate strong cross-functional collaboration and technical leadership. 

Date Posted

Closing Date