40+ Validation Engineer Interview Questions and Answers

CSV stands for Computer System Validation. Automation testing is the use of software to execute tests.

• CSV is a process of ensuring that a computer-based system meets its intended requirements and is compliant with regulatory standards.

• Automation testing involves using software tools to run tests automatically, reducing the need for manual testing.

• CSV and automation testing are often used together to ensure that computer systems are validated and tested thoroughly.

• Examples of ...read more

21 CFR part 11 is a regulation by the FDA that defines the criteria for electronic records and electronic signatures in the pharmaceutical industry.

• 21 CFR part 11 is a regulation under the Code of Federal Regulations (CFR) Title 21, which is enforced by the U.S. Food and Drug Administration (FDA).

• It sets the standards for electronic records and electronic signatures used in the pharmaceutical industry.

• The regulation ensures the authenticity, integrity, and reliability of elec...read more

GAMP guidelines are a set of principles for validation of computerized systems in pharmaceutical and biotech industries.

• GAMP stands for Good Automated Manufacturing Practice

• It provides a framework for validation of computerized systems in regulated industries

• GAMP guidelines are divided into five categories: Category 1-5

• Category 1 is for infrastructure and Category 5 is for software applications

• Gxp Project related bugs are those that affect the compliance of the system with GA...read more

There are several categories of software, including system software, application software, programming software, and malware.

• System software

• Application software

• Programming software

• Malware

Testing tools are software applications used to automate and manage the testing process.

• Automated testing tools like Selenium, Appium, and TestComplete

• Performance testing tools like JMeter and LoadRunner

• Bug tracking tools like JIRA and Bugzilla

• Code coverage tools like JaCoCo and Cobertura

• Continuous integration tools like Jenkins and Travis CI

CAN is a protocol used for communication between electronic devices in vehicles.

• CAN stands for Controller Area Network.

• It is a serial communication protocol that allows multiple electronic control units (ECUs) to communicate with each other.

• CAN uses a two-wire bus system, consisting of a CAN High (CANH) and a CAN Low (CANL) wire.

• It employs a message-based communication scheme, where each message is identified by a unique identifier (ID).

• CAN supports both standard and extended...read more

You must know programming languages like Python, Java, C++, and SQL.

• Python is commonly used for automation and data analysis

• Java is used for developing enterprise-level applications

• C++ is used for developing system software and games

• SQL is used for managing and querying databases

Validation processes in Railway Industries ensure that systems and components meet safety and performance standards.

• Validation involves testing and verifying systems, components, and processes to ensure they meet regulatory requirements.

• Validation may include functional testing, performance testing, and safety testing.

• Examples of validation processes in Railway Industries include testing signaling systems, brakes, and communication systems.

• Validation also involves documentati...read more

Categories 3 and 4 software are critical and pose high risk. Risk assessment involves identifying potential hazards and evaluating their impact.

• Category 3 software includes software that directly controls a medical device, such as infusion pumps or pacemakers.

• Category 4 software includes software that is used for critical healthcare decision-making, such as diagnostic software.

• Risk assessment for these categories involves identifying potential hazards, assessing the likelihoo...read more

Cold loop checking is done with the system off, while hot loop checking is done with the system on.

• Cold loop checking is performed when the system is not operational, to verify the wiring and connections.

• Hot loop checking is done when the system is running, to test the functionality of the loops and components.

• Cold loop checking is safer as there is no risk of equipment damage, while hot loop checking carries the risk of damaging components if not done carefully.

L2 and L3 cache are both types of memory that are used to improve CPU performance.

• L2 cache is typically located on the CPU and is faster than L3 cache.

• L3 cache is larger than L2 cache and is usually shared among multiple CPU cores.

• Both L2 and L3 cache are used to store frequently accessed data to reduce the time it takes for the CPU to access that data.

• Examples of processors with L2 and L3 cache include Intel Core i7 and AMD Ryzen processors.

RAID levels are created to improve data redundancy and performance. IO's are run to test the performance of the RAID levels.

• RAID 0 - Striping, no redundancy

• RAID 1 - Mirroring, full redundancy

• RAID 5 - Striping with parity, good balance of performance and redundancy

• RAID 6 - Striping with double parity, better redundancy than RAID 5

• RAID 10 - Combination of RAID 0 and RAID 1, high performance and redundancy

• IO's are run to test the read and write performance of the RAID levels

• Diff...read more

UDS (Unified Diagnostic Services) provides various services for communication between a diagnostic tester and an electronic control unit (ECU) in a vehicle.

• Diagnostic Session Control

• ECU Reset

• Read/Write Data By Identifier

• Security Access

• Tester Present

• Routine Control

• Request Download

• Request Upload

• Transfer Data

• Request Transfer Exit

• Control DTC Setting

• Response On Event

• Link Control

SDLC is a process used by software development teams to design, develop, test, and deploy high-quality software.

• SDLC consists of several phases including planning, analysis, design, implementation, testing, and maintenance.

• Each phase has specific goals and deliverables that must be completed before moving on to the next phase.

• Examples of SDLC models include Waterfall, Agile, and DevOps.

• SDLC helps ensure that software projects are completed on time, within budget, and meet cus...read more

Yes, I have a good understanding of Linux operating system.

• Familiar with Linux command line interface

• Experience in installing and configuring Linux servers

• Knowledge of Linux file system and permissions

• Experience in shell scripting

• Familiarity with Linux networking and security

• Examples: Ubuntu, CentOS, Red Hat

Yes, there are several well-known Pharma companies in India.

• India is one of the largest producers of generic drugs in the world.

• Some of the top Pharma companies in India include Sun Pharma, Dr. Reddy's Laboratories, Cipla, and Lupin.

• India's Pharma industry is expected to grow to $100 billion by 2025.

• The Indian government has implemented various initiatives to promote the growth of the Pharma industry, such as the 'Pharma Vision 2020' plan.

• India is also a major exporter of pha...read more

ECU is responsible for controlling various functions of a vehicle, including engine management, transmission, and emissions.

• ECU stands for Engine Control Unit

• It controls the fuel injection, ignition timing, and other engine functions

• It also manages the transmission and emissions systems

• ECUs can vary depending on the make and model of the vehicle

• Examples of ECUs include the Powertrain Control Module (PCM) and Transmission Control Module (TCM)

Validation of NVMe RAID/HBA Controller card

• Perform functional testing to ensure the card meets the required specifications

• Conduct stress testing to evaluate the card's performance under heavy workloads

• Verify compatibility with different operating systems and hardware configurations

• Document all test results and provide a validation report

CAN V and CAN P are two types of messages used in Controller Area Network (CAN) communication protocol.

• CAN V stands for CAN Voltage and is used for transmitting data at a higher voltage level.

• CAN P stands for CAN Protocol and is used for transmitting data at a lower voltage level.

• CAN V is used for high-speed communication, while CAN P is used for low-speed communication.

• CAN V is used for critical data transmission, while CAN P is used for non-critical data transmission.

• Exampl...read more

I have extensive experience in unscripted testing, including exploratory testing and ad-hoc testing.

• Performed exploratory testing to uncover defects that may not be found through scripted testing

• Conducted ad-hoc testing to simulate real-world usage scenarios

• Utilized risk-based testing to prioritize testing efforts based on potential impact

I have extensive knowledge of hardware components, interfaces, protocols, and testing methodologies.

• Familiar with various hardware components such as CPUs, GPUs, RAM, storage devices, and motherboards

• Understanding of hardware interfaces like USB, HDMI, Ethernet, and PCIe

• Knowledge of hardware protocols such as TCP/IP, SPI, I2C, and UART

• Experience in testing hardware functionality, performance, and compatibility

• Proficient in using tools like oscilloscopes, multimeters, logic an...read more

UDS stands for Unified Diagnostic Services, a protocol used in automotive electronics for communication between ECUs.

• UDS is used for diagnostic communication between ECUs in vehicles

• It is based on the ISO 14229 standard

• UDS allows for diagnostic services such as reading and clearing fault codes, accessing sensor data, and performing tests

• It uses a request-response mechanism, with the diagnostic tool sending a request and the ECU responding with a response message

• UDS is commonl...read more

Validation of SAS RAID/HBA Controller card involves testing its functionality and performance.

• Verify compatibility with the system and operating system

• Test data transfer rates and throughput

• Ensure proper RAID configuration and redundancy

• Perform stress testing to ensure stability and reliability

• Document test results and provide validation report

Validation is the process of ensuring that a system or process meets predetermined requirements. GAMP Category 5 refers to software applications that are configurable and require minimal customization.

• Validation is the process of confirming that a system or process meets predefined specifications and quality standards.

• GAMP (Good Automated Manufacturing Practice) is a set of guidelines for the validation of automated systems in the pharmaceutical and healthcare industries.

• GAMP...read more

Active safety refers to features that help prevent accidents, while passive safety refers to features that protect occupants during a crash.

• Active safety includes technologies like anti-lock brakes, traction control, and lane departure warning systems.

• Passive safety includes features like airbags, seat belts, and crumple zones.

• Active safety systems work to prevent accidents from happening, while passive safety systems activate during a crash to protect occupants.

• Both active a...read more

Validating a Gamp5 system involves following Gamp5 guidelines to ensure the system meets requirements.

• Understand Gamp5 guidelines and requirements

• Develop validation plan and protocols

• Execute validation tests

• Document results and deviations

• Review and approve validation documentation

Software testing life cycle involves planning, designing, executing, and reporting on tests to ensure software quality.

• STLC is a process that starts with test planning and ends with test closure.

• It includes test design, test execution, and test reporting.

• STLC is iterative and involves continuous improvement.

• Examples of STLC models include Waterfall, Agile, and DevOps.

To validate a linked list, check if it is properly connected, has no cycles, and all elements are accessible.

• Check if the head node is not null

• Traverse the linked list and check if each node's next pointer is valid

• Check for any cycles in the linked list using Floyd's cycle-finding algorithm

• Ensure that all elements in the linked list are accessible

An interrupt is a signal sent to the CPU to alert it of an event that needs immediate attention. ISR stands for Interrupt Service Routine, which is a function that handles the interrupt.

• Interrupt is a mechanism used by hardware devices to request attention from the CPU.

• ISR is a specific routine that is executed in response to an interrupt.

• ISRs are used to handle events that require immediate attention, such as hardware interrupts or software exceptions.

• Examples of interrupts ...read more

Yes, I have knowledge of networking.

• I have experience with TCP/IP protocols.

• I am familiar with LAN, WAN, and VPN.

• I have worked with network devices such as routers, switches, and firewalls.

• I have knowledge of network security and troubleshooting.

• I am proficient in network monitoring and analysis tools.

Understanding of computer organization is essential for a Validation Engineer to ensure proper functioning of hardware and software systems.

• Knowledge of computer architecture and components such as CPU, memory, and I/O devices

• Understanding of how data is processed and stored within a computer system

• Familiarity with computer organization principles like instruction set architecture and memory hierarchy

• Ability to troubleshoot and optimize system performance based on computer or...read more

Standard Operating Procedure (SOP) is a documented procedure that outlines the steps to be followed in a specific task or process.

• SOPs ensure consistency and quality in work processes

• They provide clear instructions to employees on how to perform tasks

• SOPs are used in various industries such as manufacturing, healthcare, and finance

• Examples of SOPs include safety procedures, quality control measures, and equipment maintenance protocols

Different versions of Windows operating system

• Different versions of Windows have different features and capabilities

• Windows 10 has a more modern interface and better security features than Windows 7

• Windows 8 introduced touch screen support and a new start screen

• Windows XP is no longer supported by Microsoft and is vulnerable to security threats

There are two types of smoke release - optical and ionization.

• Optical smoke detectors use a light source and a photosensitive receiver to detect smoke particles.

• Ionization smoke detectors use a small amount of radioactive material to ionize the air and detect smoke particles.

• Optical smoke detectors are more sensitive to smoldering fires, while ionization smoke detectors are more sensitive to flaming fires.

• Both types of smoke detectors are commonly used in buildings and homes ...read more

CSV stands for Computer System Validation. 21 CFR refers to the Code of Federal Regulations Title 21.

• CSV is the process of ensuring that a computerized system meets regulatory requirements.

• 21 CFR is a set of regulations by the FDA that governs the manufacturing, processing, packaging, and distribution of medical devices and pharmaceutical products.

• CSV is essential in industries like pharmaceuticals, medical devices, and healthcare to ensure data integrity and patient safety.

Black box testing is a software testing method where the internal structure or code of the application being tested is not known to the tester.

• Tester focuses on the functionality of the software without knowing its internal workings

• Tests are based on requirements and specifications

• Input data is provided and output is compared against expected results

• Examples include system testing, acceptance testing, and regression testing

A tuple in Python is an immutable collection of elements, similar to a list but cannot be changed once created.

• Tuples are created using parentheses ()

• Elements in a tuple can be of different data types

• Tuples can be accessed using indexing or slicing

• Tuples are faster than lists because they are immutable

There are several types of pillars in a car, each serving a different purpose.

• A-pillar: supports the windshield and connects to the roof

• B-pillar: supports the roof and connects to the floor

• C-pillar: supports the rear roof and connects to the trunk or rear deck

• D-pillar: found in some SUVs and connects the roof to the body

• Center pillar: found in some cars and connects the A-pillar to the B-pillar

ICICI Bank is a leading financial institution known for its innovative products, customer-centric approach, and strong market presence.

• ICICI Bank offers a wide range of financial products and services, including savings accounts, loans, and investment options.

• The bank has a strong reputation for its customer service and digital banking solutions.

• ICICI Bank has a widespread network of branches and ATMs, making it convenient for customers to access their services.

• The bank has w...read more

HIL stands for Hardware-in-the-Loop, a testing technique used in engineering to validate systems by simulating real-world conditions.

• HIL involves connecting physical hardware components to a simulation environment to test their interactions.

• It allows for testing complex systems in a controlled environment before deployment.

• Examples include testing automotive control systems by connecting them to a simulated vehicle environment.

• HIL testing can help identify issues early in the...read more

A turbocharger is a device that increases the efficiency and power output of an internal combustion engine.

• It uses exhaust gases to spin a turbine, which compresses the air entering the engine

• This allows more air to enter the engine, which in turn allows more fuel to be burned

• The result is increased power output without the need for a larger engine

• Turbochargers are commonly used in high-performance cars and diesel engines

Carpentry rates for panel vary depending on the type of panel, size, material, and complexity of the project.

• Carpentry rates for panel can range from $20 to $100 per square foot, depending on the material used (e.g. wood, metal, composite), size of the panel, and complexity of the design.

• Custom panels or intricate designs may cost more due to the additional labor and materials required.

• Factors such as location, market demand, and the experience of the carpenter can also influ...read more

The luster paint rate is typically measured in square feet.

• Luster paint rate is the amount of luster paint required to cover one square foot of surface area.

• It is usually calculated based on the type of paint and the desired finish.

• For example, a high-gloss luster paint may require more coats and therefore a higher rate per square foot.

Types of paints include acrylic, oil-based, water-based, and enamel.

• Acrylic paint is water-based and dries quickly

• Oil-based paint is durable and provides a glossy finish

• Water-based paint is easy to clean up with water

• Enamel paint is oil-based and provides a hard, glossy finish

Hardware and software types used in validation engineering

• Hardware: test equipment, data acquisition systems, sensors

• Software: validation software, simulation tools, data analysis tools

• Examples: oscilloscopes, LabVIEW, MATLAB