Validation Area Specialist I/II - SDF

Initial Therapeutics, Inc.; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Job summary

Novo Nordisk in Durham, NC is seeking a Validation Engineer to plan, manage and perform validation projects for manufacturing systems and equipment. You will support deviation investigations, write change requests, and collaborate with IT, Metrology and other stakeholders to ensure quality and cost effectiveness within budget.

The role requires a degree in engineering or related field and 2+ years of validation experience, with strong communication and problem-solving skills.

Qualifications

• Bachelor’s degree in engineering, pharmaceutical sciences or related field from an accredited university; 2 years validation experience.
• Alternate: Associate’s degree with 4 years validation experience.
• Alternate: High School diploma with 6 years validation experience.
• Experience with cGMP documentation practices preferred.
• Experience in core validation areas (equipment, sterilization, cleaning, process utilities or computer validation) preferred.
• Strong oral & written communication skills preferred.
• Experience with validation test equipment including Ellab Validator preferred.
• Experience working with cross-functional teams preferred.

Responsibilities

• Perform, review & approve validation/revalidation.
• Coordinate with multiple departments to schedule validation activities.
• Review & approve documents per regulatory requirements.
• Prepare and approve validation protocols and change control documents.
• Investigate deviations and apply root-cause analysis to prevent recurrence.
• Ensure data integrity and acceptance criteria are met.
• Assist audits and inspections with validation concepts and approaches.
• Support continuous improvements in validation processes.

Skills

Communication skills

Team collaboration

Problem-solving skills

Attention to detail

Technical writing

Education

Bachelor’s degree in engineering/pharmaceutical sciences or related field

Associate’s degree in engineering/pharmaceutical sciences

High School Diploma or equivalent

Tools

Ellab Validator

Microsoft Word

Excel

Job description

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.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms USfacility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

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.)

Qualifications

• 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
• 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
• Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred
• Knowledge of statistical methods preferred
• Strong oral & written communication skills 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

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

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.