Sterile Production Specialist

Kanishka
Bandara

Production Engineer

Mechatronics | Industrial Automation | HVAC Systems

A results-driven Engineer with 3+ years of experience in high-stakes pharmaceutical manufacturing. I specialize in bridging the gap between mechanical hardware and intelligent control systems, ensuring EU-GMP compliance and zero-downtime operations.

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Years Experience

ISO

Standards Expert

GMP

WHO Compliant

Audit Status

READY

// PROFESSIONAL_PROFILE

Engineering with Purpose

My journey in engineering began with a fascination for automotive dynamics, leading to a BEng (Hons) in Automotive Engineering from the University of Sunderland. This foundation in mechanical systems, thermodynamics, and control theory provided the perfect launchpad for my transition into the complex world of industrial automation.

Today, as a Production Engineer at Kelun Lifesciences, I apply those rigorous engineering principles to the pharmaceutical sector. I don't just oversee machinery; I manage the entire lifecycle of sterile production—from the validation of autoclaves to the precise calibration of BMS sensors.

My philosophy is simple: "Precision safeguards lives." In a GMP environment, a mechanical failure isn't just downtime; it's a safety risk. That’s why I focus on predictive maintenance, data-driven decision making, and strict adherence to ISO & WHO standards.

National ID

983151272V

Date of Birth

10th November 1998

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Operational Experience

2021 - Present

3 Years +

Production Engineer

Kelun Lifesciences (Pvt) Ltd, Kandy

Full Time

Machinery & Operations

➤ Maintain sterile production lines ensuring maximum uptime.
➤ Manage HVAC & AHU systems to maintain Cleanroom ISO Class 7/8 parameters.
➤ Oversee Blow Molding machinery and sterilization tunnels.
➤ Supervise WFI (Water for Injection) generation loops.

Quality & Validation

➤ Execute Validation Protocols: DQ, IQ, OQ, PQ.
➤ Prepare GMP
➤ Enforce ISO 45001 (Safety) and ISO 14001 (Environmental) protocols.
➤ Monitor BMS (Building Management System) for critical alerts.

Dec 2022 - Mar 2023

Assistant Lecture

Ceylon Robotics Industries (Pvt) Ltd

Mar 2022 - Aug 2022

Internship

Unicorn Service Center

Applicable Codes & Standards

WHO / PIC/S GMP

Global guidelines governing sterile production, validation, and documentation protocols.

ISO 9001

Quality Management System ensuring consistent production standards and process reliability.

ISO 45001

Occupational Health & Safety standards for hazard prevention and safe operations.

ISO 14001

Environmental management for emissions control and waste management.

ISO 14644-1

Cleanroom classification standards (Class 7 & 8) for facility maintenance.

ISO/IEC 17025

Competency standards for testing and calibration laboratory performance.

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Academic Qualifications

BEng (Hons) Automotive Engineering

University of Sunderland, UK

Second Class Honors - Upper Division

Core Modules Covered

Control System Designing Manufacturing System Design Automotive Dynamic Control Professional Eng. Management

Higher Diploma in Automotive Engineering

Cardiff Metropolitan University

Second Class Honors - Upper Division

Key Focus Areas

Management Principles System Maintenance Thermodynamics

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Engineering Projects & Implementations

Electric Vehicle Control System Prototype

Designed and fabricated a prototype electric vehicle focusing on energy efficiency and motor control stability. The project involved integrating an Arduino-based microcontroller to manage the powertrain, optimizing battery discharge rates and torque delivery. This demonstrated practical application of mechatronics in sustainable mobility.

ARDUINO POWER ELECTRONICS PROTOTYPING

BMS & Bio-Mass Boiler Integration

Spearheaded the official start of the BMS project with actuator installations at the AHU and completed the wiring for 20s valves. Additionally, designed and implemented a wood chip counter for the Bio-Mass boiler utilizing a custom Arduino-based circuit.

BMS ARDUINO ACTUATORS

AHU Visual Alarm System

Designed and implemented a critical visual alarm system to monitor Air Handling Unit (AHU) status. Features green/yellow indicators to signal normal operations or BMS faults, vastly improving monitoring efficiency and pre-empting equipment failures in highly sensitive sterile zones.

STERILE ZONE MONITORING

Non-PVC Water Bath Sterilization

Led the installation of a sterilization chamber for non-PVC IV bottles. Coordinated with Shinva Group for comprehensive electromechanical integration. Oversaw the sterile layout design, integrating utility systems (AHU, PS, PW, IS) and conveyor logistics, resulting in faster commissioning and higher validation success.

STERILIZATION VALIDATION LOGISTICS

In-Line Label Detection System

Installed an advanced in-line label detection system for packaging lines A and C. The automated system actively triggers alarms if a label is misaligned, damaged, or missing, significantly enhancing packaging quality control while drastically reducing labeling errors.

QUALITY CONTROL AUTOMATION