Technical Engineer

Job Summary

The Technical Engineer oversees the day-to-day operations, maintenance, and technical personnel responsible for plant utilities and building infrastructure within a regulated pharmaceutical manufacturing facility. This role ensures all GMP critical systems (cleanrooms, HVAC, clean utilities, and BMS) operate reliably, safely, and in strict compliance with cGMP, FDA/regulatory standards, and Environmental Health & Safety (EHS) guidelines.

Key Responsibilities

Team Leadership & Operations

• Supervise, roster, and mentor a shift team of multi-skilled facilities technicians, managing performance, technical training, and task allocation.

• Oversee site maintenance activities executed via the Computerized Maintenance Management System (CMMS/SAP/Maximo), tracking work order completion, PM compliance, and MTTR.

• Serve as first-line technical escalation for equipment alarms, system failures, and emergency repairs across the site.

GMP Utilities & Infrastructure Oversight

• Direct the preventive, predictive, and corrective maintenance of critical plant utilities: Purified Water (PW/WFI), Clean Steam, Clean Compressed Air (CDA), Process Gases, and Waste Treatment.

• Oversee black utilities and environmental systems: Chillers, Boilers, Cooling Towers, Emergency Generators, Fire Protection, and Cleanroom HVAC (AHUs, HEPA filtration, differential pressure cascades).

• Monitor building automation systems (BMS/SCADA) for parameter deviations (temperature, relative humidity, pressure differentials) and initiate corrective actions immediately.

Compliance, Quality & EHS

• Enforce strict Good Documentation Practices (GDP) and adherence to Standard Operating Procedures (SOPs).

• Lead deviation investigations, root cause analyses (RCA), CAPA implementations, and Change Controls related to utility upsets or facility maintenance.

• Maintain audit readiness at all times for internal audits and external regulatory inspections (e.g., FDA, EMA, local health authorities).

• Manage Permit-to-Work (PTW) protocols, Lockout/Tagout (LOTO), Confined Space Entry, and vendor safety briefings.

Vendor & Spares Management⁹

• Supervise third-party service contractors on-site, ensuring job hazard analyses and GMP vendor escort protocols are adhered to strictly.

• Manage critical spare parts inventory, monitoring safety stock levels for essential mechanical, electrical, and instrumentation components.

Qualifications & Experience

ITE/ Diploma

7+years experience