Validation Area Specialist I

Novo Nordisk • Clayton, NC

23h

About The Position

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 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 Product Supply Aseptic Manufacturing (PS AM) 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 PS AM, 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 14 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed pharmaceutical products Tuition Assistance 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. The Position Plan, manage & perform low to moderately complex validation projects and activities. Support engineers with writing change requests and conducting/writing deviation investigations. Support validation activities associated with changes to existing & new systems as assigned. Process equipment supported includes propagation, fermenters, media sterilizers and the related supporting equipment. Collaborate & coordinate with IT, Metrology & other key stakeholders to ensure quality, cost effectiveness in alignment with budget targets & timely completion of all deliverables. Relationships Reports to Manager, Director. Essential Functions Perform, review & approve validation/revalidation. Must be able to work & communicate effectively across multiple departments to schedule & perform validation/revalidation assignments Review & approve documents in accordance with local, corporate & regulatory regulations Collaborate, review & approve protocols for systems/processes per approved timeframes Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures, to include supporting investigation closure per approved timeframes using root cause analysis techniques Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria Responsible for Change Requests (CR’s) related to revalidation & other validation activities as assigned Review & approve validation procedures, specifications & quality documents for accuracy & compliance Provide support for validation concepts & approaches with audits & inspections as assigned Support change control process and identify opportunities for improvements Author & review validation procedures, specifications & quality documents for accuracy & compliance Operate in alignment with NNWay, demonstrating a Quality & cLEAN® Mindset Follow all safety & environmental requirements in the performance of duties Other duties as assigned Physical Requirements 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.)

Requirements

• Bachelor's Degree in engineering, pharmaceutical sciences or related field of study from an accredited university required and a minimum of two (2) years of validation related discipline experience in pharmaceutical or medical device industry required
• In lieu of BS degree + two (2) years of experience, may consider an Associate’s Degree in engineering, pharmaceutical sciences or related field of study from an accredited college or university required with a minimum of four (4) years of relevant validation experience in pharmaceutical or medical device industry required
• In lieu of BS degree with two (2) years of experience, may consider a High School Diploma or equivalent required with a minimum of six (6) years of relevant validation experience in pharmaceutical or medical device industry required
• Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred
• Strong oral & written communication skills preferred

Nice To Haves

• Experience in quality concepts including technical & compliance review of validation & quality documents preferred
• Experience in one or more core validation areas (equipment, sterilization, cleaning, process clean & black utilities or computer validation) preferred
• Experience in cGMP documentation practices & regulations preferred
• Knowledge of statistical methods preferred
• Experience with validation test equipment including temperature mapping equipment (for example: Ellab Validator), desired preferred
• Experience working with cross functional teams preferred
• Beginning knowledge of problem-solving using root-cause analysis techniques to solve problems preferred
• Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams a plus

Responsibilities

• Perform, review & approve validation/revalidation.
• Must be able to work & communicate effectively across multiple departments to schedule & perform validation/revalidation assignments
• Review & approve documents in accordance with local, corporate & regulatory regulations
• Collaborate, review & approve protocols for systems/processes per approved timeframes
• Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures, to include supporting investigation closure per approved timeframes using root cause analysis techniques
• Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria
• Responsible for Change Requests (CR’s) related to revalidation & other validation activities as assigned
• Review & approve validation procedures, specifications & quality documents for accuracy & compliance
• Provide support for validation concepts & approaches with audits & inspections as assigned
• Support change control process and identify opportunities for improvements
• Author & review validation procedures, specifications & quality documents for accuracy & compliance
• Operate in alignment with NNWay, demonstrating a Quality & cLEAN® Mindset
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Benefits

• 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 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees