The Position

Provide GMP knowledge and strategic support to the organization as the Site Subject Matter Expert (SME) for the Operations department. Lead and support various projects as required based on evolving business needs as it relates to GMP and quality within the operations department. Act as a coach/mentor to area Process Professionals. Communicate on behalf of Novo Nordisk with stakeholders related to projects and production. Complete assigned projects and project tasks within cost, quality and schedule requirements. Present project status updates to Senior Management.

Relationships

Reports to Manager/Director. The role is responsible for collaborating with stakeholders related to assigned area as well as other stakeholders across the site and other NN sites.

Essential Functions

• Support senior leadership as part of the department management group through participating in strategic discussions and decision making
• Responsible for area content and process knowledge, periodic reviews, validation processes and reporting
• Demonstrate technical knowledge of assigned processes to promote continuous improvement, increased productivity and cost reduction
• Facilitate and provide technical oversight for assigned processes, including assessment of deviations, root cause analysis, validation and process changes/improvements
• Evaluate process/maintenance data to propose, guide and evaluate solutions for changes and continuous process improvements via Lean tools and Six Sigma methodologies
• Present as the technical expert for assigned processes to auditors/inspectors regarding complex subject matter
• Collaborates and shares best practices with other departments and other sites of NN
• Provide support to other areas in matters related to knowledge of assigned production/process area
• Responsible for identifying and implementing process needs and improvement opportunities
• Define and support the achievement of department goals according to company objectives and strategies
• Communicate production and industry trends to team and shop floor to drive cGMP
• Implement new technologies for the process/maintenance, planning and coordinating of changes according to applicable regulatory procedures
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role.)

Qualifications

• Bachelor's degree (engineering, technology or related field of study) from an accredited university required and minimum of eight (8) years of manufacturing experience preferably in a pharmaceutical manufacturing environment
  • In lieu of Bachelor's degree and eight (8) years of experience, may consider an Associate's degree (engineering, technology or related field of study) from an accredited college or university with a minimum of ten (10) years of manufacturing experience
  • In lieu of Bachelor's degree and eight (8) years of experience, may consider a High School Diploma (GED) with a minimum twelve (12) years of manufacturing experience
• Thorough investigation and systematic problem-solving experience required
• LEAN manufacturing experience and training required
• Excellent written communication skills, investigative writing and computer skills required
• Ability to read, write and understand complicated product documentation and standard operating procedures with attention to high level concepts required
• Ability to drive continuous improvements via Lean tools and Six Sigma methodologies required
• Proven expertise in planning/organizing, managing execution, checking results, revising plans required
• Comprehensive knowledge of change control systems and Quality Management Systems (QMS) required
• Thorough validation knowledge and experience required (product/tech transfer preferred)
• General experience with regulatory audits/inspections required
• Thorough knowledge of relevant electronic manufacturing systems and master data required (ex: SAP, PAS-X, etc.)
• Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others required