Job Description
Role Overview:
We are seeking an experienced engineering leader to manage and drive site engineering operations for a sterile injectable manufacturing facility. The role involves overseeing utilities, maintenance, projects, and compliance to ensure uninterrupted and efficient plant operations aligned with global regulatory standards.
Key Responsibilities:
- Lead overall site engineering functions including maintenance, utilities, and engineering projects.
- Ensure high uptime and reliability of plant equipment and utilities systems.
- Manage sterile injectable facility equipment
- Oversee utility operations including chillers, boilers, compressors, cooling towers, and electrical systems.
- Ensure compliance with cGMP, USFDA, EU GMP, WHO, and other regulatory requirements.
- Lead engineering documentation, qualifications, and validations (IQ, OQ, PQ).