System Validation Engineer
We are seeking a skilled MES System Validation Engineer to join our team. In this role, you will be responsible for ensuring the design and development of electronic batch records (EBRs) and MES recipes meet strict GMP requirements.
The successful candidate will have experience in object-oriented programming, including Visual Basic scripting. You will work closely with manufacturing stakeholders to gather user requirements and translate them into compliant MES solutions. Your expertise in computer system validation (CSV) principles is essential in supporting live operations and delivering system improvements.
Key responsibilities include designing new EBRs and work instructions within the MES platform, modifying existing live recipes with minimal impact on manufacturing processes, producing technical documentation aligned with regulatory expectations, developing test scripts for IQ/OQ/PQ or equivalent activities, managing validation documentation using Kneat tools,and providing day-to-day support as required. ----------------------------------- Our ideal candidate has a solid understanding of GMPs, regulatory requirements, data integrity principles,and experience working within a regulated production site. We value proactive individuals who can identify issues, improve processes, deliver high-quality solutions, &&navigate complex systems.
Requirements:
1. A minimum 2+ years' experience implementing/ validating ERP/MES software at both R&D stages & live
production environments.