Validation Area Specialist II - Virginia

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 the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET's SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

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 moderately complex or cross-functional validation activities & projects. Support engineers with writing change requests and conducting/writing deviation investigations. Support validation activities associated with changes to existing & new systems. Process equipment supported includes propagation, fermenters, media sterilizers and supporting equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables.

Relationships

Reports to Manager, Director.

Essential Functions

• Perform, review & approve validation/revalidation & PSE activities. Must be able to work & communicate effectively across multiple departments to schedule & perform revalidation & PSE assignments
• Identifies and supports/performs remediation of validation compliance gaps for the department
• Review & approve documents in accordance with local, corporate & regulatory regulations
• Collaborate, review & approve protocols for systems/processes per approved timeframes
• Lead the closure of investigations per approved timeframes using root cause analysis techniques
• Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures
• Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria
• Responsible for Change Requests (CR's) related to revalidation & other validation activities
• Create, review & approve validation procedures, specifications & quality documents for accuracy & compliance
• Responsible for presentation & support for validation concepts & approaches with audits & inspections
• Lead & manage relevant validation projects and change control process and identify opportunities for improvement
• Write, review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes
• Coach, mentor and train junior level specialists
• 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.)

Qualifications

• Bachelor's Degree in engineering, pharmaceutical sciences or related field of study from an accredited university required and a minimum of five (5) years of related validation experience in pharmaceutical or medical device industry
• In lieu of BS degree + five (5) years of experience, may consider an Associate's Degree in engineering, pharmaceutical sciences or related field of study from an accredited college or university with a minimum of seven (7) years of relevant validation experience in pharmaceutical or medical device industry
• In lieu of BS degree + five (5) years of experience, may consider a High School Diploma or equivalent with a minimum of nine (9) years of relevant validation experience in pharmaceutical or medical device industry
• Experience in quality concepts including technical & compliance review of validation & quality documents required
• 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 required
• Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred
• Knowledge of statistical methods preferred
• Strong oral & written communication skills required
• Experience with validation test equipment including temperature mapping equipment (for example: Ellab Validator), desired preferred
• Experience working in cross functional teams
• Demonstrated experience using root-cause analysis techniques to solve problems required
• Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams a plus

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

We're not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

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.