Quality Control and Monitoring Systems Engineer

The Junior Quality Control and Monitoring Systems Engineer is responsible for assisting in the implementation, maintenance, and calibration of environmental and process monitoring systems used across production and laboratory facilities. This role supports compliance with GMP, GLP, and data integrity standards by ensuring accurate measurement and documentation of critical parameters such as temperature, humidity, pressure, and particle count.

Key Responsibilities:

• Support the setup, calibration, and verification of monitoring equipment and sensors.

• Participate in the installation and commissioning of environmental monitoring systems (EMS).

• Assist in executing IQ/OQ/PQ protocols, preparing test reports, and maintaining equipment records.

• Perform routine checks, identify sensor or system faults, and coordinate with vendors or service teams.

• Monitor and log data from cleanrooms, storage areas, laboratories, and production zones.

• Contribute to alarm analysis, deviation reporting, and trend reviews.

• Ensure data captured aligns with ALCOA+ principles, audit requirements, and 21 CFR Part 11 compliance.

• Work with cross-functional teams including QA, Engineering, and Validation to ensure system reliability.

Key Focus Areas:

1. Environmental & Process Monitoring Systems

   • Hands-on with:

     • Temperature/humidity/pressure monitoring

     • Cleanroom particle counters

     • Wired/Wi-Fi/LoRa-based sensor networks (e.g., Vaisala, TSI, Rotronic)

2. Quality Compliance & Documentation

   • Exposure to:

     • GMP, GDP, and GLP-compliant documentation

     • SOPs, logbooks, audit trails, and change control systems

3. Calibration & Preventive Maintenance

   • Assist in:

     • Instrument calibration and preventive maintenance

     • Maintaining calibration certificates and schedules

4. Validation Activities

   • Participate in:

     • Executing IQ/OQ/PQ protocols under guidance

     • Preparing validation reports and supporting audits

5. Data Integrity & Audit Readiness

   • Ensure:

     • Proper configuration and audit trail tracking

     • Compliance with 21 CFR Part 11 / GAMP 5

     • Backup and retrieval processes are in place

Qualifications:

• Education:

  • B.E. / B.Tech / Diploma in Instrumentation, Electronics, Biomedical, Mechatronics, or allied fields

• Experience:

  • 1–3 years in environmental monitoring, QC instrumentation, or GxP-controlled environments

• Technical Skills:

  • Knowledge of:

    • Environmental monitoring devices and calibration

    • Data logging software and dashboards

    • Basic SCADA/HMI or EMS interface tools

• Soft Skills:

  • Diligent, methodical, and accurate in documentation

  • Eager to learn and grow into compliance and system roles

  • Good communication and problem-solving ability