Grid Dynamics · 9 hours ago
Staff Software Engineer/ Architect - LIMS
San Ramon, CA
Full-time
Onsite
Lead/Staff
10+ years expGrid Dynamics is a leading provider of technology consulting and advanced analytics services. They are seeking a Staff Software Engineer/ Architect to act as a technical owner for their in-house MES platform, ensuring architectural decisions align with biomanufacturing strategies and driving technical standards across the codebase.
Big DataCloud ComputingMobile AppsOutsourcingSoftware Engineering
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
Medical insurance
Vision
Dental
Corporate social events
Professional development opportunities
Company
Grid Dynamics
Grid Dynamics is a provider of in driving enterprise-level digital transformation solutions.
1001-5000 employees
H1B Sponsorship
Grid Dynamics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (40)
2024 (29)
2023 (12)
2022 (12)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$124.5MKey Investors
Benhamou Global Ventures
2024-11-12Post Ipo Equity· $108M
2020-03-06IPO
2019-05-31Series Unknown· $15M
Leadership Team
Ilya Katsov
CTO, Americas Region
Rahul Bindlish
Vice President Strategic Sales, Emerging Business & Partnerships
Recent News
2025-12-09
2025-10-31
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