Quality Control and Monitoring Systems Engineer

As a Fresher in Quality Control and Monitoring Systems, you will support the implementation, calibration, and maintenance of quality monitoring systems used in manufacturing and lab environments. This role involves working closely with senior engineers to ensure data accuracy, system integrity, and regulatory compliance in controlled environments such as cleanrooms, labs, and production floors.

Key Responsibilities:

• Assist in the installation, testing, and configuration of environmental and process monitoring systems.

• Monitor critical quality parameters like temperature, humidity, pressure, particle counts, and other environmental metrics.

• Support validation activities including document preparation (IQ/OQ/PQ), sensor calibration, and system audits.

• Collaborate with QA/QC teams to analyze monitoring data and identify anomalies or deviations.

• Assist in maintaining and troubleshooting automated monitoring hardware/software systems.

• Maintain logs, records, and reports as per SOPs, GDP, and GMP requirements.

• Learn and apply basic principles of data integrity, alarm management, and quality risk management.

Key Focus Areas:

1. Monitoring Systems & Sensor Understanding

   • Exposure to:

     • Temperature/humidity/pressure sensors

     • Particle counters, CO₂ monitors, differential pressure gauges

     • Wired and wireless monitoring systems (e.g., Vaisala, Ellab, TSI)

2. Basic Quality Assurance Support

   • Understanding of:

     • GMP and GLP environments

     • SOP adherence, deviation reporting

     • Cleanroom classifications (ISO 14644, EU GMP Annex 1)

3. Data Integrity & Compliance Basics

   • Learning and supporting:

     • ALCOA+ principles for data quality

     • 21 CFR Part 11 / GAMP 5 guidance for computerized systems

4. Calibration & Validation Assistance

   • Assist in:

     • Equipment calibration procedures

     • Documentation of test protocols and reports

     • IQ/OQ/PQ execution support under supervision

5. Technical Documentation & Reporting

   • Participate in:

     • Generating test records, summary reports

     • Logging sensor readings and responding to excursions

     • Maintaining audit-ready documentation

Qualifications:

• Education:

  • Diploma / B.E. / B.Tech in Electronics, Instrumentation, Biomedical, Mechatronics, or related engineering streams

• Experience:

  • 0–1 year (internship or project experience in automation/quality control is a plus)

• Technical Skills:

  • Basic understanding of sensors, data logging, and instrumentation

  • Familiarity with MS Excel, basic SCADA/HMI concepts (if any), or monitoring dashboards

• Soft Skills:

  • Attention to detail and willingness to learn

  • Basic communication and documentation skills

  • Ability to follow procedures and work in regulated environments