Manager, Utilities & Metrology Technical Support

About the role

This position has the responsibility for managing and overseeing the planning, implementation, maintenance and execution of support processes related to utilities (both clean and black utilities), maintenance, and metrology. This includes equipment support, process support and GMP-related activities. This covers support for utilities in both upstream and downstream production areas, and in both our manufacturing suites for production of medicine for hemophilia and growth hormone disorders. Prior experience in a GMP and FDA manufacturing environment is a plus.

Responsibilities

• Hire, train, develop and coach team members to enable project execution at site
• Align individual performance expectations with organizational goals
• Develop performance goals collaboratively with direct reports
• Ensure that performance goals are clearly communicated and align with organizational goals
• Provide constructive and timely feedback towards performance expectations and goals
• Ensure compliance with EH&S policies and regulations. Promotes a safe and compliant work environment
• Lead, coach, and develop team members to be engaged and informed individual contributors
• Recommend and encourage continuous training and development in individual skills
• Drive a culture of HuP and cLean (Continuous Improvement)
• Identify opportunities to increase speed/efficiencies, develop and improve standards, robustness and flow, and to reduce waste (costs), process variation and error
• Support maintenance and good housekeeping of machinery, equipment, and facilities in accordance with current Good Manufacturing Practices, QMR and global regulations
• Support the evaluation, specification, installation, and validation of new, repaired or redesigned utilities/metrology equipment as required
• Ensure the validated state is maintained for utilities/metrology systems as well as Supply Chain/QC-owned controlled temperature units, including warehouses
• Perform internal audits on quality systems
• Perform periodic inspections of the manufacturing areas to ensure adherence to procedures and departmental and divisional standards
• Provide input, support and present during regulatory inspections
• Support activities in other departments as requested
• Manage annual expense budgets
• Assures all activities comply with established company policies and perform all duties in compliance with global regulatory requirements, the NNUSBPI Quality Manual and SOPs
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

Qualifications

• Education and Certifications: Associates degree or equivalent experience