Engineering Manager

The Engineering Manager will lead the engineering and maintenance functions for the Oncology Manufacturing Facility, ensuring reliability, compliance, and operational excellence. The role requires deep expertise in sterile and injectable pharmaceutical environments, with a strong focus on equipment performance, utilities management, and team leadership.

Key Responsibilities:

1. Maintenance and Reliability Management

• Oversee maintenance operations to ensure optimal performance of production equipment, including lyophilizers, injectable filling lines, and rapid mixer grinders.
• Develop and execute preventive maintenance programs to minimize downtime and ensure uninterrupted manufacturing.
• Monitor equipment performance and implement continuous improvement initiatives.

2. Utilities and HVAC Management

• Manage all plant utilities, including water treatment plants, WFI (Water for Injection) systems, and compressed air systems.
• Oversee operation and maintenance of Air Handling Units (AHUs) and cleanroom HVAC systems to maintain environmental conditions in compliance with GMP standards.

3. Engineering Operations

• Lead engineering projects involving installation, qualification, and validation of new equipment and facility upgrades.
• Collaborate cross-functionally to assess production capacity, equipment utilization, and workflow enhancements.
• Drive expansion initiatives aligned with organizational growth and regulatory requirements.

4. Regulatory Compliance and Audit Readiness

• Ensure compliance with regulatory standards including US FDA, UK MHRA, and EMA for all engineering and maintenance activities.
• Prepare and maintain documentation to support audits, inspections, and validation activities.
• Maintain up-to-date records of calibration, maintenance, and equipment validation.

5. Budgeting and Cost Optimization

• Develop and manage annual engineering budgets, ensuring cost efficiency in maintenance and procurement.
• Implement cost-saving measures while safeguarding reliability and compliance standards.
• Track and analyze maintenance expenses and resource utilization.

6. Team Leadership and Development

• Lead, mentor, and motivate the engineering and maintenance teams to foster technical excellence and proactive problem-solving.
• Conduct performance evaluations and build a culture of accountability, safety, and continuous learning.
• Ensure adequate manpower planning and skill development to meet operational demands.

Required Qualifications and Experience

Education:

• Bachelors degree in Mechanical, Electrical, or Chemical Engineering (mandatory).
• Master's degree or certification in Engineering Management or related field preferred.

Experience:

• 10–15 years of experience in pharmaceutical manufacturing, with a minimum of 5 years in a managerial capacity.
• Proven experience managing sterile manufacturing equipment and utilities (lyophilizers, injectable filling lines, WFI systems, HVAC, etc.).

Technical Knowledge:

• In-depth understanding of GMP, GEP, and other regulatory requirements applicable to sterile and injectable facilities.
• Hands-on experience with CMMS (Computerized Maintenance Management System) and engineering project management tools.
• Proficiency in troubleshooting, root cause analysis, and reliability improvement methodologies.

Skills:

• Strong leadership, analytical, and decision-making capabilities.
• Excellent communication and cross-functional collaboration skills.
• Knowledge of energy management, sustainability practices, and automation technologies in pharmaceutical operations.

Key Attributes

• Strategic mindset with attention to operational detail.
• Commitment to quality, safety, and compliance.
• Ability to thrive in a dynamic and highly regulated environment.