Purpose
- This role undertakes projects related to system provisioning, installations, configurations as well as monitoring and maintenance of systems.
- Applies highly developed specialist knowledge and skills in systems administration, onboarding of Manufacturing, Lab Systems or Shopfloor devices and works toward continuous optimization of system performance.
- Implements system improvements and is required to be on standby with on-call availability to resolve systems related incidents.
- Works in a team setting and is proficient in Manufacturing systems, Lab systems, network connectivity and security standards, integration environments between Manufacturing & Lab OT and Enterprise systems and takes care of the data security requirements for systems to operate in ABS environment.
- Able to quickly and effectively solve issues as they arise, and methodically identify the cause of the issue, evaluate it and develop a solution in collaboration with the team. Able to communicate effectively and displays high service level standards.
Business Analysis
- Elicit and analyze business requirements from key stakeholders and assess relevant solutions and their potential impact in the Manufacturing, Lab and Enterprise environments.
- Evaluate factors and ideas to identify key business requirements and objectives to be achieved.
- Recommend business activities required to integrate and roll out new changes and drive the execution of change control procedures, engaging stakeholders in the process.
System & Operation Support
- Provide first level support to Operations Users and drive resolution on shopfloor related incidents for BTS supported IT/OT systems.
- Execute crisis management plans (e.g. PIAB, BCP, etc) for identified critical manufacturing & lab systems and assist in the coordination of major systems downtime or disruption events.
- Performs systems administration support such as user access, user access recertification, systems audit trail review, backup and restore, data archival, shopfloor qualification and coordination of systems patching/systems downtime activities.
- Acts as a Subject Matter Expert/trainer for Manufacturing, Lab & Enterprise systems (E.g. POMS, SM12, Empower, OSI PI, SAP).
- Lead in investigation arising out of products or Quality processes, security non-compliance to perform product impact assessment, root cause analysis and to ensure effective corrective action and preventive actions to prevent recurrence.
Projects
- Plan and drive medium scale projects or programs, including allocating resources to different parts, and engaging stakeholders on the project's progress and outcomes.
- Manage local/global projects through robust deployment plan (includes developing training needs, develop test cases, perform qualification and post support of the change) for Manufacturing, Lab & Engineering.
Continuous Improvement
- Analyze and develop, review of plans for process improvement and optimization (e.g. support regulatory requirements, process improvements initiatives, resource assessment, deployment methods and Considerations in generating and translating process improvement ideas into workable concepts).
- Any other responsibilities or tasks as assigned by your Supervisor/Manager.
Qualifications
- A diploma or bachelor’s degree in IT, Engineering or Chemical Engineering.
- Min 5 years of experience as IT system analyst, IT consultant, or involved in IT system support required.
- Min 2 years of working experience in a GMP manufacturing environment.
- Working knowledge of Manufacturing IT/OT systems (e.g. Manufacturing Execution System (MES), Laboratory System, Enterprise Resource Planning (ERP)) is required.
- Proficiency in tools and technology relevant to systems analysis including working experience with software development tools, database management systems and data modeling tools.
- Basic process knowledge in pharmaceutical manufacturing preferred.
- Good understanding of system development life cycle (SDLC) as well as SDLC methodologies such as Waterfall, Agile, DevOps.
- Understanding of various programming languages (e.g. C#, Python, R, VBA), database management (e.g. SQL), and network infrastructure is preferred.
- Ability to exercise agility in a cross-functional environment.
- Good verbal and written communication skills.
- Problem solving abilities.
- Adaptability and flexibility.
- High degree of initiative and ownership and ability to work with several different departments in a fast-paced environment.
