Validation Area Specialist III - Virginia

BioSpace; Petersburg (VA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Parental & family leave

Tuition assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk seeks a Senior Validation SME to plan, manage and perform high-complexity validation activities for our Petersburg, Virginia site. You will support engineers with change requests, deviations, and validation plans across equipment, sterilization, cleaning, and computer validation, coordinating with IT and metrology.

You will mentor junior staff, lead investigations, ensure protocol data meets criteria, and drive improvements with a risk-based validation mindset while adhering to

Qualifications

• Bachelor’s Degree in Engineering, Pharmaceutical Sciences or related field; 7+ years of validation experience in pharma/medical devices.
• Alternative: Associate’s Degree with 9+ years of validation experience.
• Alternative: High School Diploma with 11+ years of validation experience.

Responsibilities

• Provide SME level guidance on validation activities and projects.
• Lead investigations and root-cause analyses for validation issues.
• Review and approve validation/revalidation and pse activities.
• Identify and remediate validation compliance gaps.
• Prepare and approve validation documents and protocols; support audits and inspections.

Skills

Validation

Root cause analysis

Quality systems

Project management

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Associate’s degree in engineering (alternative)

High School Diploma or equivalent (alternative)

Tools

Ellab Validator

Temperature mapping equipment

Microsoft Word

Microsoft 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.

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

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

Strong Oral & Written Communication Skills Required

• 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.