Job Title: Maintenance and Utilities Expert
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* This role is responsible for running and maintaining utilities in line with cGMP and regulatory requirements.
The position provides overall guidance and support as to the running and compliance of plant utilities.
Key Responsibilities:
* Site SME for utilities system with overall responsibility for the compliant operation of assigned utility systems.
* Ensure all Clean Utility systems are running in line with regulatory requirements.
* Utilize problem-solving techniques such as root cause analysis methods to establish root causes to any issues that may arise and implement robust corrective measures.
* Responsible for ensuring that all utilities remain operational, available for use and GxP compliant at all times.
Utilities Operations
* Setup and review of contracts with relevant stakeholders.
* Input into site utility master planning efforts to ensure utility design and capacity can meet site and business needs.
Maintenance and Calibration
* Ensure maintenance & calibration is carried out in accordance to cGMP regulations, safety considerations and site quality standards.
Reporting and Analysis
* Generate, report and analyse key utility metrics.
Regulatory Compliance
* Ensure compliance with cGMP regulations and local quality procedures.
Education and Qualifications
* Bachelor's degree in Engineering (Mechanical, Electrical, or related field).
* 8+ years of facilities engineering experience, preferably in biopharmaceutical manufacturing.
* Proven leadership and team management skills.
Required Skills and Qualifications
* Strong knowledge of Utilities, Clean Utilities (RIW, WFI and Steam), Grey Utilities (Boilers, Chillers, Cooling Towers, Heat Pumps, Air Compressors, WWTP) and HVAC systems including cleanrooms.
* Familiarity with regulatory requirements, GMP standards and audit experience.
About This Role
* This is a challenging opportunity to work on complex utilities projects and contribute to the growth and success of our organization.
Contact Information
* To be considered for this role, please visit our careers page to complete the application process.