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I will pharmaceutical engineering for gmp compliance expertise
Mechanical Engineer Pressure Equipment and Industrial Design
Technical Director and Senior Mechanical Engineer with 25+ years of experience designing pressure equipment, autoclaves, and thermal systems. I help manufacturers and engineering firms with calculatio...
About this Gig
I am a Mechanical Engineer with over 8 years of specialized experience in the pharmaceutical and biotech sectors (AZBIL TELSTAR, PHARMA BIOS). My expertise includes equipment design, validation documentation, and ensuring full GMP compliance across all project stages.
I provide technical consulting to translate your URS (User Requirement Specifications) into compliant and functional designs, validation protocols, and traceability documentation.
My experience includes Technical Director oversight, guaranteeing quality and full regulatory conformity from concept to commissioning.
Software I work with:
- SolidWorks (3D design, stress simulations, assemblies)
- AutoCAD / DraftSight (2D engineering drawings)
- COMSOL Multiphysics (thermal & structural analysis)
- Excel advanced engineering calculations (VBA optional)
- EN 13445 / ASME VIII compliant calculation tools
- GMP documentation tools (IQ/OQ/PQ templates, risk analysis ISO 14971)
Contact me to ensure your next project meets all regulatory, design, and traceability requirements with professional precision.
Domain:
Consulting
Industry:
Biotech
•
Medical & pharmaceutical
Language:
Catalan
•
English
•
Spanish
My Portfolio
FAQ
What information do you need to start the project?
To begin, I need your URS (User Requirements Specification), technical drawings (if available), standards to comply with (GMP, EN 13445, ASME, ISO 14971, etc.), and any internal templates you want me to follow. If you don’t have these, I can help you define them.
What is the typical delivery time?
Delivery time depends on project complexity, but most documents (designs, reports, validation files) are delivered within 3–7 days. Larger engineering calculations or full GMP documentation packages may require 1–3 weeks. Contact me for an exact timeline.
Do you offer revisions?
Yes. All packages include professional revisions to ensure the final document fully matches your expectations and regulatory requirements. Additional revisions can be added if needed.
Can you work with confidential or proprietary documentation?
Absolutely. I can sign an NDA upon request, and all project files are handled with strict confidentiality following industry standards.
Can you deliver urgent or same-day orders?
Yes, express delivery is available depending on current workload and project scope. Please message me before placing an urgent order.
Do you follow GMP, EN 13445, ASME, or ISO standards?
Yes, I work according to the required standards for your project: GMP, EN 13445-3, ASME VIII, ISO 14971, ISO 9001, pressure equipment regulations, and internal pharma quality systems.
Which software do you use?
I use SolidWorks, AutoCAD, COMSOL Multiphysics, and advanced Excel engineering worksheets aligned with EN 13445 / ASME VIII formulas.
