Operations Engineer

ROLE OVERVIEW

We are seeking an experienced Operations Engineer to join the Centralized Manufacturing Services (CMS) team, supporting Media and Buffer operations within a GMP-regulated biopharmaceutical manufacturing environment. This role covers a broad scope across shop-floor operations, MES and SAP systems support, documentation and validation, and new product introduction activities.

KEY RESPONSIBILITIES

• Set up and support Media and Buffer operations on the shop floor
• Develop and maintain MES work instructions and electronic batch records for buffer and media
• Review and test MES Process Instructions to ensure accuracy and compliance
• Create and maintain SAP master data for buffer and media
• Perform gap assessments and support implementation of controls
• Author and update process SOPs and related documentation
• Author, review, and approve validation protocols/reports, and lead execution activities
• Support commissioning, water run, and engineering run phases, along with project tasks related to Material Preparation

REQUIREMENTS

• Degree in Engineering, Life Sciences, or related discipline (or equivalent experience)
• Minimum 5 years of relevant experience in GMP manufacturing or operations
• Hands-on experience setting up and running media and buffer operations
• Practical MES experience, ideally including new MES project delivery
• Experience with DeltaV or similar distributed control systems
• Experience in new product transfer/introduction to manufacturing systems and shop-floor operations
• Working knowledge of SAP master data for buffer and media
• Good understanding of GMP and data integrity for electronic systems
• Strong problem-solving and communication skills