Guru Samy Paulraj

Project Manager – Technical & Operational Delivery

Delivering technical operations, facility readiness, and regulated project execution in the biopharmaceutical sector with 20+ years of experience

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Guru Samy Paulraj

Professional Highlights

20+
Years Experience
10+
Years in Saudi Arabia
PMP®
Certified Professional
DBA
Pursuing Doctorate
BSc, MBA
Academic Degrees

Core Expertise

Project Management

  • Greenfield Facility Development
  • Cross-Functional Leadership
  • Budget & Resource Management
  • Risk Mitigation Planning
  • Vendor & Contractor Management

Technical Operations

  • Fill-Finish Manufacturing
  • Cleanroom Qualification
  • Equipment IQ/OQ/PQ
  • Serialization Systems (L3-L4)
  • GMP-Compliant Utilities

Regulatory Compliance

  • EU-GMP, cGMP, WHO Standards
  • SFDA, EMA, US FDA Familiarity
  • Technical Due Diligence
  • Validation Master Plans
  • GDP/GMP Manufacturing

Strategic Partnerships

  • Licensing & Alliance Management
  • M&A Due Diligence
  • Contract Negotiations
  • Technology Transfer
  • Stakeholder Engagement

Professional Experience

Manager – Technical Operations

Vaccine Industrial Company
March 2025 - Present
  • Coordinate with the COO in technical oversight of early construction for the vaccine fill–finish facility
  • Coordinate with EPC contractors, engineers, and vendors to resolve technical and site issues.
  • Ensure GMP requirements are followed during construction and installation.

Business Development Manager

SAUDIBIO
December 2021 - February 2025
  • Provided critical support in negotiating and finalizing Contract Manufacturing Agreements (CMAs) with leading global pharmaceutical companies, facilitating mutual growth and optimizing the utilization of Saudibio's manufacturing capabilities.
  • Played a pivotal role in the due diligence process for the acquisition of Saudibio by a prominent Company (PIF Company) to secure a successful deal.
  • Collaborated with the team to conduct comprehensive contract manufacturing due diligence with industry giants(Roche, Janssen Biologics, Sandoz, and Biocon), highlighting Saudibio’s capabilities and contributing to the alignment with global quality and regulatory standards.

Project Manager (Technical)

SAUDIBIO
October 2016 - November 2021
  • Led Serialization implementation integrated with SFDA's RSD
  • Managed the project of Packaging lines commissioning, qualification and validation
  • Coordinated equipment qualification programs (IQ/OQ/PQ)
  • Coordinated Implementation of GMP-compliant utility systems including purified water and compressed air
  • Conducted facility audits and technical capability assessments
  • Led the implementation of IT/OT & BMS Projects

Various Project & Business Development Roles

Pharmaceutical & Medical Technology Companies
March 2004 - September 2016 | India & Saudi Arabia
  • Progressive roles in project management and technical operations
  • Comprehensive experience in Medical, pharmaceutical manufacturing and quality systems
  • Foundation development in GMP operations and validation practices

Get In Touch

📞 Phone

+966 50 879 8982

📧 Email

pg@samy.guru

📍 Location

Riyadh, Saudi Arabia

🌐 Website

www.samy.guru