As the Clean Utilities Subject Matter Expert (SME), you will provide technical leadership to the HVAC/Autoclave technicians and the site utilities team. Your responsibilities will include identifying gaps, developing strategies, and implementing improvements to ensure clean utilities remain current and aligned with all operational and maintenance requirements. Additionally, you will oversee HVAC/Autoclave maintenance, assisting with planning and implementation to support Engineering Supervisors effectively.
The Clean Utilities SME will be responsible for effective, reliable, and cost-effective operation of the site’s HVAC/Autoclaves within their facilities, maintaining all these systems in a state of compliance, in-control, and fit for use, capable of meeting all site needs. This role will also drive continuous improvement initiatives, cost saving and other department initiatives. Responsibilities: Subject Matter Expertise:
Function as the technical expert on clean utility systems, including purified water, water for injection, clean steam, compressed gases, autoclaves, and HVAC systems. System Oversight:
Ensure oversight of operation and maintenance of clean utility systems to ensure compliance with GMP standards in sterile and controlled manufacturing environments. Compliance Management:
Ensure all clean utility systems meet regulatory and quality standards, driving proactive measures for audits and inspections. Operational Excellence:
Collaborate with the Engineering Team Manager to align clean utility operations with organisational objectives, driving efficiency and performance improvements. Strategic Guidance:
Provide specialised expertise to support project delivery, resource planning, and strategic decision-making related to clean utilities. Continuous Improvement:
Identify and implement process improvements to optimise clean utility system performance and maintain compliance with evolving regulations. Leadership and Training:
Mentor and train engineering and operations teams on best practices for clean utility systems management, fostering a culture of technical excellence. Cross-Functional Collaboration:
Partner with manufacturing, quality, and maintenance teams to ensure seamless integration of clean utility systems into broader operational workflows. Qualifications: Educational Background:
Bachelor’s degree in Engineering, Biotechnology, or a related field. Advanced degrees preferred but not essential. Experience:
10+ years of experience of clean utility systems in a GMP-regulated manufacturing environment, with a demonstrated stakeholder management roles. Technical Proficiency:
Deep knowledge of clean utility systems, including purified water, water for injection, clean steam, compressed gases, autoclaves, and HVAC systems. Regulatory Expertise:
Strong understanding of GMP, FDA, and EU regulatory requirements related to clean utilities. Problem-Solving Skills:
Proven ability to troubleshoot complex technical issues and implement effective solutions in a fast-paced environment. Project Management:
Experience with supporting projects related to clean utility systems, including system upgrades, compliance initiatives, and operational improvements. Leadership and Communication:
Good interpersonal skills, with the ability to influence and guide cross-functional teams. Continuous Improvement Mindset:
Demonstrated history of driving process improvements and operational efficiencies. Certifications:
Relevant certifications such as Certified Pharmaceutical Industry Professional (CPIP), Six Sigma, or equivalent are not essential but are favourable. This position is on Monday - Friday, standard office hours.
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The Clean Utilities SME will be responsible for effective, reliable, and cost-effective operation of the site’s HVAC/Autoclaves within their facilities, maintaining all these systems in a state of compliance, in-control, and fit for use, capable of meeting all site needs. This role will also drive continuous improvement initiatives, cost saving and other department initiatives. Responsibilities: Subject Matter Expertise:
Function as the technical expert on clean utility systems, including purified water, water for injection, clean steam, compressed gases, autoclaves, and HVAC systems. System Oversight:
Ensure oversight of operation and maintenance of clean utility systems to ensure compliance with GMP standards in sterile and controlled manufacturing environments. Compliance Management:
Ensure all clean utility systems meet regulatory and quality standards, driving proactive measures for audits and inspections. Operational Excellence:
Collaborate with the Engineering Team Manager to align clean utility operations with organisational objectives, driving efficiency and performance improvements. Strategic Guidance:
Provide specialised expertise to support project delivery, resource planning, and strategic decision-making related to clean utilities. Continuous Improvement:
Identify and implement process improvements to optimise clean utility system performance and maintain compliance with evolving regulations. Leadership and Training:
Mentor and train engineering and operations teams on best practices for clean utility systems management, fostering a culture of technical excellence. Cross-Functional Collaboration:
Partner with manufacturing, quality, and maintenance teams to ensure seamless integration of clean utility systems into broader operational workflows. Qualifications: Educational Background:
Bachelor’s degree in Engineering, Biotechnology, or a related field. Advanced degrees preferred but not essential. Experience:
10+ years of experience of clean utility systems in a GMP-regulated manufacturing environment, with a demonstrated stakeholder management roles. Technical Proficiency:
Deep knowledge of clean utility systems, including purified water, water for injection, clean steam, compressed gases, autoclaves, and HVAC systems. Regulatory Expertise:
Strong understanding of GMP, FDA, and EU regulatory requirements related to clean utilities. Problem-Solving Skills:
Proven ability to troubleshoot complex technical issues and implement effective solutions in a fast-paced environment. Project Management:
Experience with supporting projects related to clean utility systems, including system upgrades, compliance initiatives, and operational improvements. Leadership and Communication:
Good interpersonal skills, with the ability to influence and guide cross-functional teams. Continuous Improvement Mindset:
Demonstrated history of driving process improvements and operational efficiencies. Certifications:
Relevant certifications such as Certified Pharmaceutical Industry Professional (CPIP), Six Sigma, or equivalent are not essential but are favourable. This position is on Monday - Friday, standard office hours.
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