Senior General Manager - Engineering

Role Overview

This position leads engineering and projects activities at the plant, with responsibility for maintenance, utilities, compliance, and cross-functional coordination to support production and quality goals.

Engineering and Project Execution

• Manage new projects and modification activities from concept and layout development through installation, commissioning, and validation documentation.
• Oversee resource planning and assign responsibilities across the team.
• Drive plant maintenance engineering services so production requirements are met on time.
• Use structured tools, methods, and periodic review meetings to track progress and resolve issues.
• Support quality management system activities by coordinating with cross-functional teams.
• Review preventive maintenance plans, user requirement specifications, risk-mitigation plans, and cGMP-related documents for equipment.
• Handle any additional responsibilities assigned by senior leadership as needed.

Utilities, Compliance, and External Coordination

• Ensure utilities are available with minimal downtime and optimum equipment efficiency.
• Coordinate with government authorities such as the Boiler Inspector and similar officials when required.
• Identify and implement initiatives that reduce consumption of power, fuel, water, and other resources.

Data Integrity and GxP Expectations

• Follow Good Documentation Practices and Data Integrity requirements in all GxP-related activities and records at the site.
• Ensure the team understands the importance of Data Integrity and the consequences of non-compliance.
• Review GxP records and reports with Data Integrity compliance in mind for all job-related outputs.
• Ensure any suspected data breach is managed in line with the SOP for handling potential Data Integrity observations.
• Participate in self-inspections as an auditor and conduct scheduled self-inspection activities.
• Prepare self-inspection reports and review follow-up compliance reports.

Technical Requirement

• The candidate must have practical maintenance exposure to sterile process machines.