The PositionProvide 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.
RelationshipsReports 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 providing in-depth deviation investigations and root cause analysis
- Drive continuous improvements via Lean tools and Six Sigma methodologies and certifications
- Responsible for area content and process knowledge
- Identify and implement process needs and improvement opportunities for moderate to high complexity issues
- Responsible for periodic reviews and reporting. Involved with collaboration across sites
- Update and manage area master data and recipes as needed
- Provide support on defined issues and contributes through application of expertise and knowledge
- Follow all safety & environmental requirements in the performance of dutiesOther duties as assigned
Physical RequirementsAbility to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 20% 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 preferred) from an accredited university required and a minimum of three (3) years of manufacturing experience required, preferably in a pharmaceutical manufacturing environment
- In lieu of Bachelor's degree plus three (3) years of experience, may consider an Associate's degree (engineering, technology or related field of study preferred) in technology or related field of study from an accredited college or university with a minimum of five (5) years of manufacturing experience required
- In lieu of Bachelor's degree plus three (3) years of experience, may consider a High School Diploma or equivalent with a minimum of seven (7) years of manufacturing experience required. Excellent written communication skills required
- Thorough investigation and systematic problem-solving experience required
- LEAN manufacturing experience and training required
- General knowledge of change control systems and Quality Management Systems (QMS) required
- Relevant electronic manufacturing system experience required (ex: SAP, PAS-X, etc.)
- Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others preferred
- General experience with regulatory audits/inspections required
- Knowledge of relevant master data preferred
- Validation experience preferred
- Product transfer (or tech transfer) experience a plus
