About the Position:
Ensuring seamless operation of utility systems is critical to our organization's success.
The successful Utilities Manager will oversee the compliant operation of clean utilities, grey utilities, and HVAC systems.
Responsibilities include serving as site SME for utilities system, ensuring regulatory compliance, utilizing Six Sigma tools, and generating reports on key utility metrics.
Key qualifications include a Bachelor's degree in Engineering, 8+ years of facilities engineering experience, and strong knowledge of utilities, clean utilities, and HVAC systems.
Leadership and team management skills are essential, as well as familiarity with regulatory requirements, GMP standards, and audit experience.
This role is a mid-senior level position within the Technical Operations group, responsible for creating drugs for clinical trials and scaling production for the commercial market.
Core Responsibilities:
1. Site SME for utilities system
2. Ensure all clean utility systems are running in line with regulatory requirements
3. Ensure all HVAC systems are running in line with critical area classification standards and parameters
4. Utilize Six Sigma tools to establish root causes and implement corrective measures
5. Responsible for ensuring utilities remain operational, available, and GxP compliant at all times
6. Setup and review of contracts with QA Representatives
7. Input into site utility master planning efforts
8. Ensure maintenance & calibration is carried out in accordance with cGMP regulations
9. Generate, report, and analyze key utility metrics
10. Participate in HAZOP and design reviews
11. Ensure all engineering drawings and documentation are maintained in compliance with relevant cGMPs and GEPs
12. Identify critical spare parts required for equipment
13. Planning and execution of site utility shutdowns
14. Ensure Compliance with Environmental responsibilities for Waste Water and Storm water systems
15. Oversee facility repairs, installations, and maintenance projects
16. Prepare budgets and forecasts for operational expenses
17. Ensure contractor training and documentation compliance
18. Lead investigation teams and manage CAPAs for facility-related issues