Validation Area Specialist III - Virginia

Novo Nordisk A/S; Petersburg (VA); On-site; USD 90,000 - 135,000; Full time

Benefits offered by this job

Health Insurance and benefits from day

401K with company match

Paid time off and holidays

Tuition Assistance

Job summary

Join Novo Nordisk in Petersburg, VA as a Subject Matter Expert for validation activities across high-complexity projects. You will support engineers, write change requests and deviations, and coordinate with IT, metrology and stakeholders to ensure timely, quality deliverables.

You will mentor junior team members, lead investigations, and ensure compliance with regulatory requirements while advancing Novo Nordisk's SMOL and ET initiatives.

Qualifications

• Bachelor's Degree in Engineering, Pharmaceutical Sciences or related field required with 7+ years of validation experience.
• Experience in quality concepts including technical and compliance review of validation documents is required.
• Experience in core validation areas (equipment, sterilization, cleaning, process clean, utilities or computer validation) is required.
• cGMP documentation practices and regulations knowledge is required.

Responsibilities

• Provide SME knowledge and guidance on validation activities, initiatives and projects.
• Lead and perform validation/revalidation activities and review documents.
• Identify and remediate validation compliance gaps within the department.
• Review and approve validation protocols, specifications and quality documents for accuracy and compliance.
• Lead root cause analysis and implement corrective actions to prevent recurrence.
• Collaborate with multiple departments to plan and execute revalidation assignments.

Skills

Validation expertise

Root cause analysis

Cross-functional collaboration

Quality systems

Documentation review

Communication skills

Education

Bachelor's in Engineering/Pharmaceuticals

7+ years validation experience

Tools

Ellab Validator

Job description

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Location: Petersburg, VA, US

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 14weeks 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

Serve as the Subject Matter Expert (SME) for planning, managing & performing high complexity validation activities and projects. Support engineers in writing change requests, deviation investigation & writing. 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. Serve as a mentor to junior team members.

Relationships

Reports to Manager, Director.

Essential Functions

• Provide SME level knowledge and guidance to team members and stakeholders regarding validation activities, initiatives and projects
• Resolve validation related issues through actions leading to rapid, effective decision-making, to include sharing decision with team members and stakeholders in a timely and clear manner
• Perform, review & approve validation/revalidation & PSE activities
• 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
• Handle deviations related to revalidation & other validation activities
• Responsible for Change Requests (CR’s) related to revalidation & other validation activities
• Review & approve validation procedures, specifications & quality documents for accuracy & compliance
• Presentation & support for validation concepts & approaches with audits & inspections
• Translate procedural requirements within the validation area into practical workflows guiding the project execution
• Identify & implement improvements that support risk-based validation execution for the site
• Build strong cross-functional relations with Novo Nordisk project organization & validation project contributors (local & abroad)
• 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, with a minimum of seven (7) years of relevant validation experience in the pharmaceutical or medical device industry required
• In lieu of BS degree with a minimum of seven (7) years of experience, may consider an Associate’s Degree in engineering, pharmaceutical sciences or related field of study from an accredited university required with a minimum of nine (9) years of relevant validation experience in pharmaceutical or medical device industry required
• In lieu of BS degree with a minimum of seven (7) years of experience, may consider a High School Diploma or equivalent required with a minimum of eleven (11) years of relevant validation experience in pharmaceutical or medical device industry required
• 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) required
• Experience in cGMP documentation practices & regulations required
• Must be able to work & communicate effectively across multiple departments to schedule & perform revalidation & PSE assignments
• Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred
• Knowledge of statistical methods preferred
• Experience with validation test equipment including temperature mapping equipment (for example: Ellab Validator), desired preferred
• Demonstrated experience using root-cause analysis techniques to solve problems required
• Expert in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams a required

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.