Clean Utilities Senior Specialist

Job Description

An amazing opportunity has arisen for a Clean Utilities Engineer in our state-of-the-art facility.

The utilities engineer is responsible for the design, implementation, and maintenance of clean utility systems that ensure a safe and compliant environment for pharmaceutical or biotechnology manufacturing processes. The role encompasses system validation, troubleshooting, and continuous improvement of water, steam, and gas systems to meet regulatory standards and operational efficiency. The primary focus of the position is on GMP/clean utilities and operations (WFI, Clean Steam, HVAC and Process Gasses).

They will act as Subject Matter Expert for assigned equipment and play a key role to ensure that the site is Safe and Compliant.

What you will do:

• Ensure compliance to all Safety, regulatory GMP and Environmental requirements.
• Perform risk assessments, system validations, and qualifications for clean utility processes to ensure they meet cGMP (current Good Manufacturing Practices) regulations.
• Conduct routine inspections and maintenance on clean utility systems to ensure optimal performance and compliance with safety and quality standards.
• Collaborate with cross-functional teams, including production, quality assurance, and regulatory affairs, to resolve issues related to clean utilities and provide technical support.
• Investigate equipment failures or deviations to find root cause and implement effective Corrective and Preventative Actions.
• Monitor and analyse system performance data to identify opportunities for improvement in efficiency and reliability.
• Develop and maintain standard operating procedures (SOPs) and documentation for clean utility operations and maintenance.
• Provide training and guidance to operations personnel on clean utility systems and best practices.
• Stay current on industry trends, technologies, and regulations related to clean utilities and recommend upgrades or changes as needed.
• Support Engineering Excellence Initiatives – participate in local and corporate programs.
• Own the initiation, management and closure of change initiatives.
• Support regulatory audits on clean utility systems.
• Be responsible for adherence to site and corporate QMS for clean Utility Systems and Point of contact for Quality Alerts and Bulletins for Utility Systems. Review and prepare formal responses.
• Complete periodic reviews and other compliance documentation aligned with the site Quality Management System.
• Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan.
• Lead technical cross-functional teams and work across engineering areas to deliver robust and sustainable solutions and business processes.
• Drive functional commitments on initiatives and provide high level of oversight and coordination to seamlessly integrate utility engineering efforts within the site.
• Pursues and use new technologies and methodologies, consult with other subject matter experts and site on procedures and to ensure design solutions achieve long term business objectives and are supported by robust technical rationale.

Qualifications

In order to excel in this role, you will more than likely have:

• A Level 8 qualification in an engineering discipline (preferred)
• 5 + years Engineering Utilities experience in a Biologics Manufacturing Site.
• Strong knowledge of clean utility systems design, regulatory requirements, and industry standards (e.g., FDA, EMA, cGMP).
• Experience of Operations and Maintenance of Clean Utilities Systems i.e. Water, HVAC, Process Gasses.
• In-depth knowledge of regulatory requirements and an ability to provide solutions that reflect understanding of business objectives and cost implications.
• Knowledgeable of mechanical, electrical, control and automation systems maintenance requirements.
• Knowledge and experience of commissioning and validation of HVAC and Clean Utilities systems
• Experience of continuous improvement and optimisation techniques.
• Excellent organising, planning skills, and communication skills.
• Proven success working in a team environment with flexibility to react to changing business needs.
• High level of attention to detail and strong problem-solving abilities.
• Stakeholder management of multi-decision makers, colleagues, peers, and cross functional teams.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Requisition ID:R340948