Software Engineer

We are looking for a highly specialized Software Developer to own the end-to-end design, custom development, validation, and deployment of enterprise Manufacturing Execution System (MES) software layers. This role sits at the intersection of core software engineering and highly regulated pharmaceutical production environments.

Key Responsibilities

- Architect, develop, and code complex digital manufacturing recipes, workflows, and configurations utilizing Siemens Opcenter Execution Pharma and Werum PAS-X (v3.1.8).

- Write, optimize, and maintain relational database structures (SQL, Oracle) and engineer data connections between the MES software layer and factory automation devices via Kepware OPC platforms.

- Code and test software changes in alignment with Computer System Validation (CSV) workflows, strictly adhering to FDA 21 CFR Part 11 and GMP regulations.

- Deliver Level 3 software development support, including debugging complex production issues, writing code patches, and performing comprehensive Root Cause Analysis (RCA) during site hypercare deployment phases.

- ead client technical sprint reviews, translate business constraints into functional code requirements, and mentor junior development team members.

Job Requirements

- Bachelor’s Degree in Computer Science, Software Engineering, or a highly related technical field.

- Minimum of 5 years of solid software development and deployment experience, specializing heavily in the life sciences/pharmaceutical production domain.

- Hands-on development proficiency with MES software suites.

- Highly proficient with SQL, Oracle, database scripting, and Agile development methodologies (Jira).

- Strong working knowledge of Computer System Validation (CSV) protocols and data integrity regulations (21 CFR Part 11).