Maitsys
Experience: 10+ years (12–15+ preferred)
About the Role Maitsys Inc. is seeking a highly skilled AI Architect with strong experience in pharmaceutical manufacturing, GxP/GMP environments, and enterprise-scale AI solution design. This role will define AI architecture frameworks, lead the technical design of GenAI and intelligent automation platforms, and ensure full alignment with regulatory and compliance requirements.
The AI Architect will support strategy, solutioning, and technical delivery across AI initiatives that include GenAI, agentic AI, RAG systems, manufacturing intelligence, and data-driven decision automation. This role requires deep architecture expertise, strong cross-functional collaboration, and the ability to translate complex business needs into scalable AI solutions.
Key Responsibilities AI Architecture & Technical Leadership
GenAI, LLMs, agentic AI
RAG architectures and vector databases
MLOps platforms and cloud AI services
Develop enterprise AI blueprints, design patterns, and reusable frameworks.
Ensure architecture meets GxP/GMP, ALCOA+, 21 CFR Part 11, and Annex 11 requirements.
Support AI platform integration across MES, LIMS, QMS, ELN, SCADA, ERP, and manufacturing data systems.
Provide architectural governance and lead technical design reviews.
AI Strategy Support & Business Advisory
Partner with manufacturing, QA/QC, labs, and supply chain stakeholders to identify high-value AI use cases.
Translate business needs into AI-enabled workflows and automation opportunities.
Support preparation of AI roadmaps, maturity models, and implementation strategies.
Facilitate workshops to drive AI readiness and operational adoption.
Solution Delivery & Technical Translation
Convert business processes into detailed architectural and technical requirements.
Guide engineers, data scientists, and platform teams throughout model development and deployment.
Explainability
Validation & compliance
Secure and scalable deployment
Oversee implementation of AI agents, copilots, knowledge assistants, and domain-specific automation solutions.
Compliance, Governance & Data Integrity
Architect AI systems aligned with:
GMP/GxP
21 CFR Part 11
EU Annex 11
CSV/CSA guidelines
Collaborate with QA, validation, cybersecurity, and compliance teams to ensure proper documentation and controls.
Practice Enablement & Cross-functional Leadership
Mentor junior architects and engineering teams.
Contribute to accelerators, playbooks, reusable assets, and architectural standards.
Support proposal development, pre-sales activities, and client advisory discussions.
Represent Maitsys in industry forums and thought leadership initiatives.
Required Qualifications
10–15+ years of experience in Pharma, Biotech, or other regulated manufacturing environments.
Strong understanding of GxP/GMP, CSV/CSA, and regulatory compliance frameworks.
Deep expertise in designing enterprise AI/ML, GenAI, and agentic AI architectures.
Hands‑on experience with:
AWS, Azure, or GCP cloud ecosystems
MLOps, model governance, CI/CD, monitoring, and validation
Proven ability to influence senior stakeholders and communicate with both technical and business teams.
Experience leading cross‑functional solution delivery teams.
Preferred Qualifications
Experience with GAMP 5, AI validation frameworks, or regulated system integration.
Familiarity with:
LIMS (LabWare/STARLIMS)
QMS (TrackWise/Veeva)
Manufacturing data lakes and historian systems
Background in consulting, digital transformation, or enterprise architecture.
Certifications such as TOGAF, MBA, or an advanced degree in AI/ML/Data Science.
Why Join Maitsys?
Drive AI transformation in global pharmaceutical manufacturing.
Lead enterprise-level GenAI and automation initiatives.
Collaborate with a fast‑growing, innovation‑focused organization.
Opportunity to shape and scale Maitsys’s AI architecture practice.
Work closely with executive leadership in a strategic role.
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Information Technology
Industries
IT Services and IT Consulting
#J-18808-Ljbffr
About the Role Maitsys Inc. is seeking a highly skilled AI Architect with strong experience in pharmaceutical manufacturing, GxP/GMP environments, and enterprise-scale AI solution design. This role will define AI architecture frameworks, lead the technical design of GenAI and intelligent automation platforms, and ensure full alignment with regulatory and compliance requirements.
The AI Architect will support strategy, solutioning, and technical delivery across AI initiatives that include GenAI, agentic AI, RAG systems, manufacturing intelligence, and data-driven decision automation. This role requires deep architecture expertise, strong cross-functional collaboration, and the ability to translate complex business needs into scalable AI solutions.
Key Responsibilities AI Architecture & Technical Leadership
GenAI, LLMs, agentic AI
RAG architectures and vector databases
MLOps platforms and cloud AI services
Develop enterprise AI blueprints, design patterns, and reusable frameworks.
Ensure architecture meets GxP/GMP, ALCOA+, 21 CFR Part 11, and Annex 11 requirements.
Support AI platform integration across MES, LIMS, QMS, ELN, SCADA, ERP, and manufacturing data systems.
Provide architectural governance and lead technical design reviews.
AI Strategy Support & Business Advisory
Partner with manufacturing, QA/QC, labs, and supply chain stakeholders to identify high-value AI use cases.
Translate business needs into AI-enabled workflows and automation opportunities.
Support preparation of AI roadmaps, maturity models, and implementation strategies.
Facilitate workshops to drive AI readiness and operational adoption.
Solution Delivery & Technical Translation
Convert business processes into detailed architectural and technical requirements.
Guide engineers, data scientists, and platform teams throughout model development and deployment.
Explainability
Validation & compliance
Secure and scalable deployment
Oversee implementation of AI agents, copilots, knowledge assistants, and domain-specific automation solutions.
Compliance, Governance & Data Integrity
Architect AI systems aligned with:
GMP/GxP
21 CFR Part 11
EU Annex 11
CSV/CSA guidelines
Collaborate with QA, validation, cybersecurity, and compliance teams to ensure proper documentation and controls.
Practice Enablement & Cross-functional Leadership
Mentor junior architects and engineering teams.
Contribute to accelerators, playbooks, reusable assets, and architectural standards.
Support proposal development, pre-sales activities, and client advisory discussions.
Represent Maitsys in industry forums and thought leadership initiatives.
Required Qualifications
10–15+ years of experience in Pharma, Biotech, or other regulated manufacturing environments.
Strong understanding of GxP/GMP, CSV/CSA, and regulatory compliance frameworks.
Deep expertise in designing enterprise AI/ML, GenAI, and agentic AI architectures.
Hands‑on experience with:
AWS, Azure, or GCP cloud ecosystems
MLOps, model governance, CI/CD, monitoring, and validation
Proven ability to influence senior stakeholders and communicate with both technical and business teams.
Experience leading cross‑functional solution delivery teams.
Preferred Qualifications
Experience with GAMP 5, AI validation frameworks, or regulated system integration.
Familiarity with:
LIMS (LabWare/STARLIMS)
QMS (TrackWise/Veeva)
Manufacturing data lakes and historian systems
Background in consulting, digital transformation, or enterprise architecture.
Certifications such as TOGAF, MBA, or an advanced degree in AI/ML/Data Science.
Why Join Maitsys?
Drive AI transformation in global pharmaceutical manufacturing.
Lead enterprise-level GenAI and automation initiatives.
Collaborate with a fast‑growing, innovation‑focused organization.
Opportunity to shape and scale Maitsys’s AI architecture practice.
Work closely with executive leadership in a strategic role.
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Information Technology
Industries
IT Services and IT Consulting
#J-18808-Ljbffr