Pharma Engineering Knowledge Base

A living reference repository anchoring professional experience in pharmaceutical engineering to peer-reviewed academic literature, built as a foundation for continuous learning and future AI-powered projects.

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👤 About

Julien Sisavath — Pharmaceutical Engineering Professional (Switzerland)
Background in maintenance methods coordination, GMP compliance, Oracle CMMS/ERP, and cross-functional operations in regulated API manufacturing environments.

• 📍 Fribourg, Switzerland
• 🏭 Experience: Celgene International II Sàrl (now WuXi AppTec), Couvet NE
• 🎯 Target: Infrastructure & Utilities Engineering in CDMO biologics (Lonza Visp)

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📁 Repository Structure

pharma-engineering-knowledge-base/
│
├── 01_celgene-memoir/          ← Post-project memoir — Celgene 2018–2019
│   ├── README.md
│   ├── section_1_gmp_framework.md
│   ├── section_2_cmms_oracle.md
│   ├── section_3_kpis.md
│   ├── section_4_cross_functional.md
│   ├── section_5_products.md
│   ├── section_6_gmp_docs_capa.md
│   └── section_7_conclusion_industry4.md
│
├── 02_lonza-research/          ← Preparation dossier — Lonza Visp I&U Engineer
│   ├── README.md
│   ├── section_1_equipment_reliability.md
│   ├── section_2_sme_capex_cqv.md
│   ├── section_3_troubleshooting_capa.md
│   ├── section_4_gmp_utilities_biologics.md
│   ├── section_5_hpapi_containment.md
│   ├── section_6_cross_functional_capex.md
│   ├── section_7_she_compliance.md
│   └── section_8_conclusion_cdmo_market.md
│
├── 03_future-projects/         ← Ideas & roadmap for AI-powered projects
│   └── IDEAS.md
│
└── README.md                   ← This file

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🎯 Purpose

This repository serves three functions:

1. Reference archive — Academic-grade documentation of hands-on pharmaceutical engineering experience, anchored in peer-reviewed literature via Consensus
2. Interview preparation — Structured knowledge base demonstrating readiness for senior engineering roles in CDMO biologics
3. Launchpad — Starting point for future AI agent projects in pharma/engineering domains

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🔑 Key Topics Covered

GMP cGMP FDA 21 CFR Part 211 SwissMedic Oracle CMMS ERP OEE MTBF MTTR CAPA SOP Deviation Management ALCOA Equipment Qualification IQ/OQ/PQ CDMO Biologics HPAPI CIP/SIP WFI Utilities CAPEX Projects Industry 4.0 Predictive Maintenance AI Agents TPM RCM FMEA

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📚 Methodology

All academic sections were built using Consensus — an AI-powered academic search tool — to find peer-reviewed literature supporting each theme. No proprietary or confidential site data is disclosed. All references are publicly accessible.

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🚀 Future Projects

See en/03_future-projects/IDEAS.md for the AI project roadmap.

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This repository is actively maintained and expanded. Contributions and feedback welcome.