Senior Executive Engineering

Role Summary

Responsible for managing Calibration Systems, Engineering QMS, Utility Operations & Maintenance, and Project Execution in a GMP-compliant Oral Solid Dosage (OSD) facility. Ensures regulatory compliance, high equipment reliability, and uninterrupted manufacturing operations.

Key Responsibilities

Calibration Management:

- Monitor and maintain calibration program for GMP-critical instruments.

- Ensure traceability (NABL/ISO 17025) and 100% compliance

- Handle OOT, deviations, and CAPA related to calibration

- Maintain records as per written procedures.

Engineering QMS:

- Monitor Change Controls, Deviations, CAPA, and Risk Assessments related to Engg.

- Ensure compliance with cGMP and Data Integrity (ALCOA+)

- Prepare/review SOPs and applicable Engineering related documents.

- Support regulatory audits (NPRA, CQA, Internal)

Utility Operations & Maintenance:

- Oversee HVAC, PW systems, boilers, chillers, compressors

- Maintain cleanroom conditions (temp., RH, DP)

- Ensure >99% uptime of utilities

- Implement preventive & predictive maintenance.

- Optimize energy usage and cost.

Project Management:

- Execute equipment installation, commissioning & qualification

- Manage DQ/IQ/OQ/PQ activities

- Coordinate with QA, Production, Vendors

- Ensure projects meet timelines, budget & compliance

Equipment & Facility Management:

- Support OSD equipment (Granulation, Compression, Coating, Packing) maintenance

- Ensure lifecycle management and qualification compliance

Compliance & Safety:

- Ensure audit readiness and timely closure of observations

- Adhere to EHS and statutory requirements

Qualifications

B.E./B.Tech (Mechanical/Electrical/Instrumentation). Certification in QMS, PM etc.. will be added advantage

Experience

6–8 years in Pharma manufacturing / Medical Devise. Exposure to regulatory audits.

Key Skills

cGMP & regulatory compliance, HVAC & utility systems, calibration & validation, project management, troubleshooting.

Key KPIs

Calibration compliance: 100% | Utility uptime: ≥99% | Zero critical audit observations | CAPA closure on time | Project delivery adherence