Full Time Junior Computer System Validation (CSV) Engineer Jobs, Salary up to MYR 3,000 in Innovatz Global Johor - Maukerja

Job Overview

We are looking for a motivated and detail-oriented Junior Computer System Validation (CSV) Engineer to join our team in Johor. This is an excellent opportunity for fresh graduates who are interested in IT, software validation, quality, compliance, and regulated environments.

The selected candidate will support Computer System Validation activities, documentation, testing, and compliance processes under the guidance of experienced team members.

Key Responsibilities

• Assist in Computer System Validation (CSV) activities throughout the system lifecycle.
• Support preparation and maintenance of validation documents, including:
• User Requirement Specifications (URS)
• Risk Assessments
• Validation Plans
• Test Scripts / Test Protocols
• Traceability Matrix (RTM)
• Validation Reports
• Assist with execution and documentation of IQ/OQ/PQ testing activities.
• Support software/system testing and verification activities.
• Review test results and maintain appropriate validation evidence and records.
• Assist in ensuring computerized systems meet defined business, technical, quality, and compliance requirements.
• Support change control, deviation, CAPA, and periodic review activities related to validated systems.
• Maintain accurate and organized validation documentation.
• Work closely with IT, QA, Engineering, Operations, and business teams.
• Support audit and inspection readiness activities.
• Follow established SOPs, quality procedures, and documentation standards.
• Learn and apply industry practices related to GxP, GMP, CSV, and data integrity.

Required Qualifications

• Bachelor's Degree / Diploma in:
• Computer Science
• Information Technology
• Software Engineering
• Computer Engineering
• Engineering
• Life Sciences
• Pharmacy
• Biotechnology
• or a related discipline.
• Fresh graduates are welcome to apply.
• Basic understanding of software development, software testing, or IT systems.
• Good documentation and analytical skills.
• Strong attention to detail.
• Good written and verbal communication skills.
• Willingness to learn Computer System Validation and regulatory compliance.
• Ability to work effectively with cross-functional teams.
• Willingness to work from Johor, Malaysia.

Good to Have

Candidates with knowledge or academic exposure to any of the following will have an advantage:

• Computer System Validation (CSV)
• GAMP 5
• GMP / GxP
• FDA 21 CFR Part 11
• EU Annex 11
• Software Development Life Cycle (SDLC)
• Software Testing / QA
• Risk Assessment
• Data Integrity / ALCOA+
• IQ / OQ / PQ
• Change Control
• CAPA
• Validation Documentation

Technical Skills

• Basic knowledge of MS Office, particularly Word and Excel.
• Basic understanding of software applications and databases.
• Familiarity with testing concepts and test cases is an advantage.
• Basic understanding of SDLC and documentation processes.

Key Competencies

• Analytical and problem-solving mindset
• Strong attention to detail
• Good documentation skills
• Willingness to learn
• Team player
• Good communication skills
• Organized and responsible
• Ability to work in a regulated environment

Career Opportunity

This role is suitable for fresh graduates looking to build a career in Computer System Validation, IT Quality, Software Quality Assurance, CSV/CSA, GxP Compliance, and Life Sciences IT.

Freshers with a strong interest in CSV and regulated IT environments are encouraged to apply.

Pay: RM1,883.95 - RM3,000.00 per month

Work Location: In person