About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Oral Finished Products (OFP) tableting facility in Durham, NC sits on 194,000 square feet of state-of-the-art equipment and supports the production of our innovative oral treatments for patients with type 2 diabetes. Employees work across Bulk Production, Packaging, Warehouse, Business Support, QC and QA. At OFP, you’ll join a global network of manufacturing professionals who are passionate about what they do and committed to helping us meet the growing demand for our treatments.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance – reimbursement up to $10,000 annually
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

Position Purpose

Coordinate & drive implementation of project management best practices for investment projects, new process development projects, & technology transfer projects at OFP US. Maintain strong working relationship between project teams, CMC, MDev, corporate process groups, QA, Bulk, Packaging, QC, & Warehousing. The incumbent will set requirements, build/construct, design, commission & perform verifications for projects according to science & risk-based validation (SRV). Execute projects & manage all aspects including develop project goals & business objectives; finalize scope & budget; create project plans; including staffing negotiations with LOB; monitor & control project work; manage project data; report performance & seek approvals from steering group; manage project procurement, delivery/installation, completion/turnover, change control, & resource management; close & evaluate each project.

Accountabilities

• International coordination for product development & product transfer activities within OFP US & DK Manufacturing Development departments
• Maintain detailed implementation timelines for new product introduction activities in relation to overall site objectives & provide updates to local stakeholders & international stakeholders
• Provide oversight & harmonize the Environmental Monitoring program for production areas & manage routine monitoring activities as appropriate
• Provide oversight & harmonize the equipment cleaning program & manage routine cleaning monitoring activities as appropriate
• Create detailed implementation plans for equipment cleaning & facility environmental monitoring program changes when new equipment is purchased, or production capacity is increased
• Maintain detailed site capacity tools used to assess feasibility of new product introductions &/or building/equipment modifications
• Provide oversight & manage the Cleaning Validation Master Plan
• Provide input into the Site Validation Master Plan
• Provide input into regulatory submission(s) & filing
• Provide oversight & management for PV Reporting & associated activities
• Provide oversight & management for master Batch Records & associated activities
• SME/Single point of contact for internal & external inspections
• Harmonization for EM & Cleaning for international & corporate standards
• Provide oversight & harmonization for the SRV validation aspect of new equipment implementation within the production area, including maintaining detailed validation schedules
• Participate in testing & implementation of new equipment
• Change agent for projects. Leads & implements change management activities in support of risk-based validation
• Follow all safety & environmental requirements in the performance of duties
• Responsible for adherence to mechanism for monitoring project progress, intervention & problem solving with other work package managers or shop floor personnel
• Responsible for information exchange
• Responsible for communications to management & other pertinent units
• Assist with any training required of personnel supporting the project
• Responsible for development & execution of projects identified as process needs & improvement opportunities
• Review scientific documents
• Remain up to date regarding new technologies within oral solid dose
• Prepare documentation for authorities & reports for registration applications
• Order & purchase of goods, services & equipment as needed
• Contribute to scientific knowledge exchange & idea generation in the team & department
• Communicate & coordinate with laboratory personnel
• Other accountabilities, as assigned

Required Qualifications

• BA/BS degree in engineering or related technical field or equivalent combination of education & experience
• Minimum of six (6) years of engineering experience in facility infrastructure as well as manufacturing experience in a pharmaceutical environment
• Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts
• New product introductions
• Initiative, ability to function independently
• Good judgment in decision making as well as very good leadership skills
• Functions well in team environment

Desired Qualifications

• Advanced Project Management competencies obtained through relevant PM training or experience
• Minimum of five (5) years proven project / portfolio management skills with major capital projects
• P&ID, HVAC, electrical systems, & computer literacy
• Basic understanding of contractual documents & ability to create work plans & detailed project schedules
• Building/equipment modifications
• Proven project management experience with direct management of multiple projects simultaneously
• Proven expertise in mentoring/development, planning/organizing, managing execution, & revising the work plan for complex problems solved by cross functional teams

Physical & Other Requirements

• Ability to work hours necessary to support a 24/7 continuous manufacturing operation
• Constantly operates a computer & other office equipment using hands
• Ability to work in an open office environment with the possibility of frequent distraction
• Occasionally moves equipment &/or supplies weighing up to 33 lbs. within the facility using various body positions
• Routinely operates & inspects manufacturing equipment using hands
• Ability to adjust schedule to work with colleagues in other international time zones
• Ability to travel internationally, as requested (up to 20%)

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.