Job Description
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About the Company: AI Driven Automation Architect – Pharma Manufacturing
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About the Role
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Location: San Francisco Bay Area (Hybrid/Onsite) Type: Contract Function: Digital Manufacturing, Automation, AI/ML Role Summary We are seeking a hands on AI Automation Architect with deep expertise in designing and deploying end to end AI powered business process automation within pharmaceutical manufacturing environments. This role focuses on requirements collection, intelligent workflow design, and process optimization across complex, regulated operations. The ideal candidate brings strong technical execution capabilities, GxP awareness, and a proven ability to modernize manufacturing processes through scalable AI and automation frameworks.
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Responsibilities
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Requirements Gathering & Process Analysis
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- Lead structured requirement collection sessions with manufacturing, QA, QC, supply chain, and IT teams.
- Map current state workflows, identify bottlenecks, and document functional/technical requirements.
- Translate business needs into AI driven automation specifications and workflow logic.
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AI Powered Automation & Intelligent Workflow Design
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- Architect and deploy AI enabled workflows that reduce manual effort and improve operational efficiency.
- Build automation frameworks leveraging ML models, rule based engines, and intelligent orchestration tools.
- Integrate automation solutions with MES, LIMS, ERP, and other manufacturing systems.
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Process Optimization & Digital Transformation
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- Identify automation opportunities across batch execution, deviation management, equipment readiness, data capture, and compliance workflows.
- Drive modernization of end to end manufacturing processes using AI, analytics, and digital tools.
- Partner with cross functional teams to accelerate digital transformation initiatives.
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Compliance, Validation & Data Integrity
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- Ensure all automation solutions meet GxP, 21 CFR Part 11, validation, and data integrity requirements.
- Collaborate with QA/Validation teams to define testing, documentation, and change control processes.
- Implement explainable AI and traceable decision logic within automated workflows.
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Cross Functional Collaboration & Stakeholder Management
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- Work closely with manufacturing, quality, IT, data engineering, and automation teams.
- Communicate technical concepts clearly to non technical stakeholders.
- Provide ongoing support for deployment, troubleshooting, and continuous improvement.
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Preferred Qualifications
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- Experience with digital manufacturing platforms (MES, LIMS, eBR, EBR automation).
- Familiarity with cloud based AI/automation services (Azure, AWS, GCP).
- Background in intelligent document processing, predictive analytics, or workflow orchestration.
- Prior experience driving digital transformation in regulated environments.
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Required Skills & Experience
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- Strong experience in AI/ML, intelligent workflows, and process automation.
- Proven background in pharma/biotech manufacturing or other regulated industries.
- Expertise in requirements gathering, business process analysis, and workflow design.
- Hands on experience with automation tools, orchestration platforms, and data pipelines.
- Solid understanding of GxP, validation, data integrity, and compliance frameworks.
- Ability to design scalable automation architectures that integrate with MES/LIMS/ERP systems.
- Excellent communication, documentation, and stakeholder management skills.
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Preferred Skills
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Ideal Candidate Profile A hands on builder who can:
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- Collect requirements with precision
- Architect AI driven workflows
- Execute automation solutions end to end
- Ensure compliance and validation
- Modernize manufacturing operations through scalable digital systems
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