EXECUTIVE

Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Lead and supervise daily activities related to calibration, maintenance, and repair of instrumentation and automation systems used in pharmaceutical manufacturing.

Ensure all critical instruments and control systems are calibrated and maintained according to GMPcompliant procedures and schedules.

Support equipment qualification IQOQPQ and requalification activities in coordination with validation and QA.

Troubleshoot automation issues affecting process performance or compliance and implement corrective actions.

Oversee alarm management, control strategy optimization, and PLC logic modifications in collaboration with process engineering.

Manage system backups, user access, and cybersecurity compliance for automated systems.

Maintain comprehensive documentation including calibration records, change controls, and deviation reports.

Drive continuous improvement projects related to automation reliability, system integration, and digital transformation e.g., paperless operations, smart devices.

Coordinate with external vendors for advanced repairs, upgrades, and service contracts.

Train and mentor technicians and junior engineers on instrumentation systems, automation architecture, and compliance practices.

Ensure audit readiness at all times by maintaining robust documentation, traceability, and compliance controls.

Key Decisions

Assigning and prioritizing calibration and maintenance tasks based on criticality and production schedules.

Approving changes to instrumentation or control systems that may impact validated processes.

Selecting vendors or contractors for automation and calibration services.

Making decisions on alarm rationalization, software patching, or upgrades to ensure system integrity and compliance.

Responding to deviations, system failures, or audit observations with appropriate CAPAs and systemic improvements.

Managing resource allocation and shift planning for instrumentation support during production and shutdown activities.

Determining training needs and competence assessments for technical team members.