Staff Software Engineer/ Architect - LIMS

Essential functions

• Act as a technical owner for major parts of the in-house MES platform

• Ensure architectural decisions align with biomanufacturing strategy, GxP requirements, and industry best practices

• Drive technical standards, design patterns, and engineering best practices across the MES codebase

• Contribute hands-on across the full SDLC: requirements analysis, system design, implementation, testing, validation, deployment, and support

• Translate complex manufacturing workflows and SOPs into robust software solutions

• Continuously improve existing MES functionality, performance, and usability

• Work closely with Manufacturing Operations, Quality, Process Development, Platform Architecture, and Infrastructure teams

• Serve as a technical bridge between software engineering and manufacturing stakeholders

• Ensure accuracy, integrity, traceability, and security of manufacturing data

• Compliance & Validation: Ensure our custom MES solutions comply with GxP regulations (e.g., cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols and documentation, specifically tailored for custom software.

Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or a related technical field. Master's degree preferred.

• 10+ years of progressive experience in software development and technical leadership, with at least 3 years specifically focused on designing, developing, implementing, and managing complex enterprise software solutions, preferably in a manufacturing or industrial automation context.

• Proven leadership experience.

• Direct experience with LIMS concepts Laboratory Information Management System.

• Demonstrated expertise in software architecture, design patterns, and full-stack development.

• Proficiency in one or more relevant programming languages (e.g., C#, Java, Python, .NET, JavaScript frameworks like React/Angular/Vue) and database technologies (e.g., SQL Server, Oracle, PostgreSQL).

• Extensive knowledge of GxP regulations (especially cGMP), FDA 21 CFR Part 11, and Eudralex Annex 11, with practical experience applying them to custom software development and validation.

• Understanding of biotechnological and biopharmaceutical manufacturing processes (e.g., liquid handling, molecular biology protocols, cell culture, fermentation, purification, aseptic filling, media/buffer prep, etc.)

• Strong analytical, problem-solving, and decision-making abilities, with a keen eye for detail in a regulated context.

• Exceptional communication, interpersonal, and presentation skills, with the ability to influence stakeholders at all levels and effectively communicate complex technical and regulatory concepts.

  
  

Would be a plus

• Experience with specific biopharmaceutical manufacturing processes or modalities (e.g., cell and gene therapy, mAbs, vaccines).

• Open to experience from other industries such as semiconductor.

• Familiarity with Industry 4.0 concepts, IoT, and advanced manufacturing technologies in a biotech context, with an understanding of how to integrate them into a custom MES.

We offer

• Opportunity to work on cutting-edge projects
• Work with a highly motivated and dedicated team
• Competitive salary
• Flexible schedule
• Benefits package - medical insurance, vision, dental, etc.
• Corporate social events
• Professional development opportunities
• Well-equipped office

About us

Grid Dynamics (NASDAQ: GDYN) is a leading provider of technology consulting, platform and product engineering, AI, and advanced analytics services. Fusing technical vision with business acumen, we solve the most pressing technical challenges and enable positive business outcomes for enterprise companies undergoing business transformation. A key differentiator for Grid Dynamics is our 8 years of experience and leadership in enterprise AI, supported by profound expertise and ongoing investment in data, analytics, cloud & DevOps, application modernization and customer experience. Founded in 2006, Grid Dynamics is headquartered in Silicon Valley with offices across the Americas, Europe, and India.