Novo Nordisk Inc Hiring for Validation Area Specialist – Site Capacity job in Clayton Full Time

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. 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 legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic “fill and finish” site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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

Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.

Accountabilities

• Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols
• Ownership of Change Requests (CR’s) related to project validation responsibilities
• Perform compliance & technical reviews/approvals of protocols & protocol data
• Author project quality masterplans (PQMP’s), validation plans (VPL’s), & other key validation documentation
• Author & execute assigned IV, OV & PV protocols for direct impact systems/processes per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for validating new systems
• Ensure compliance of validation protocols executed are aligned with local, corporate & regulatory regulations
• Lead validation failure investigations & non-conformities utilizing root cause analysis techniques
• Create & modify existing validation procedures & configuration item lists (CIL’s) as required
• Write/Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes
• Participate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment
• Identify process improvements before equipment, systems or processes are placed under change control during validation
• Budget oversight as needed
• Contractor scheduling & oversight as needed
• Leads validation activities assigned by overall project manager
• Other accountabilities, as assigned

Required Qualifications

• BA/BS degree in Engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience
• Minimum of seven (7) years validation or quality related discipline experience in pharmaceutical environment
• Experienced with regulatory requirements & industry standards for pharmaceutical &/or medical device manufacture, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration items list, FDA & ICH guidance documents

Desired Qualifications

• MA/MS/MBS degree preferred
• Demonstrated experience using root-cause analysis techniques to solve problems
• Ability to read, write & understand complicated product documentation
• Demonstrated leadership & project management skills: two-way communication skills with customers (internal/external), project team & management; interpersonal & team building skills; achievement of project timelines & customer requirements
• Ability to write technical documentation based on equipment manuals
• Experience in pharmaceutical manufacturing preferred. Knowledgeable in GMP concepts
• Knowledge of standard operating procedures with attention to high-level concepts
• Ability to manage multiple tasks/deadlines & prioritize properly based on process needs
• Demonstrated strong skills in change management within Novo Nordisk (NN)

Physical & Other Requirements

• Occasionally moves equipment &or supplies weighing up to 33 pounds within the facility using various body positions
• Constantly operates a computer & other office equipment using hands
• 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 work the hours necessary to support the project & 24/7 continuous manufacturing operation once in production
• Ability to travel internationally, up to 10% of the time
• Ability to adjust schedule to work with colleagues in other international time zones

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.