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