Role Summary:
Responsible for leading engineering operations in a pharmaceutical manufacturing environment, ensuring equipment reliability, regulatory compliance, and continuous improvement of production processes.
Key Responsibilities:
- Manage all engineering and maintenance activities across production lines and utility systems (HVAC, water systems, compressed air, etc.).
- Ensure compliance with GMP, safety standards, and regulatory requirements.
- Plan and execute preventive and corrective maintenance to minimize downtime and maintain operational efficiency.
- Oversee installation, commissioning, and validation of new equipment and systems.
- Collaborate with Production, Quality Assurance, and Regulatory teams to ensure smooth manufacturing operations.
- Lead troubleshooting and root cause analysis of equipment failures and process issues.
- Develop and manage engineering budgets, cost control, and resource allocation.
- Supervise and mentor engineering team members to enhance productivity and performance.
- Maintain proper documentation including SOPs, maintenance logs, and validation reports.
- Drive continuous improvement initiatives to enhance efficiency, safety, and product quality.