Job Description – Validation Supervisor
Location: Bloomington, United States
Job Category: Quality
Schedule: Monday – Friday, 8:00 AM – 5:00 PM
About Novo Nordisk
At Novo Nordisk, we have been at the forefront of diabetes care for more than 100 years. Today, our focus extends beyond diabetes to improve the quality of life for millions worldwide.
Our Bloomington, Indiana site is a state-of-the-art facility that integrates process and formulation development, clinical and commercial biomanufacturing, and drug product fill/finish and packaging. Our teams work collaboratively with innovators to manufacture and supply high-quality products to patients globally.
What We Offer
Competitive pay with annual performance bonus
Generous paid time off, including 14 paid holidays
Health, Dental, and Vision Insurance effective from day one
401(k) with 8% guaranteed contribution plus company match option
Family-focused benefits, including 14 weeks paid parental leave and 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition assistance
Life & disability insurance
Employee referral awards
Career growth opportunities, mentorship, and resources to help you realize your potential
Position Summary
The Validation Supervisor will lead and oversee validation activities related to equipment, cleaning, computer systems, media fill (APS), and process validation. This role provides technical oversight, supervises validation personnel, and ensures compliance with regulatory guidance and company policies.
Reports to: Manager, Validation
Supervisory Responsibilities: Yes
Key Responsibilities
Equipment Validation
Develop qualification strategies and documents for new systems
Evaluate change controls and determine required qualification activities
Provide technical oversight and training to junior staff
Participate in regulatory inspections and responses
Cleaning Validation
Develop qualification strategies and documentation for new systems and products
Computer System Validation
Apply GAMP principles and ensure compliance across multiple system types
Media Fill (APS) Validation
Develop qualification strategies for novel processes
Manage client communications and regulatory responses related to APS
Process Validation
Review change controls and assess process impacts
Lead client communications for process validation topics
General Responsibilities
Supervise validation personnel, provide guidance, and support career development
Oversee complex equipment validation projects
Review and approve deviations related to validation
Maintain Commissioning, Qualification, and Validation Master Plans (CQVMP)
Ensure systems remain in a qualified/validated state through periodic reviews and requalification
Support internal audits, including response preparation and corrective actions
Act as SME for qualified/validated systems
Lead cross-functional initiatives and oversee validation contractors
Provide technical training and maintain controlled documents
Ensure compliance with safety and environmental requirements
Physical Requirements
Frequent sitting, standing, walking, reading, and computer use
Occasional stooping, kneeling, bending, and lifting (up to 50 lbs)
Ability to work in controlled cleanroom environments
Qualifications
Education & Experience
High School/GED with 6+ years relevant experience, OR
Bachelor’s degree in STEM field with relevant experience
1+ year GMP or regulated industry experience required
0–1 year leadership experience preferred
Technical Skills
Strong written and verbal communication skills
Ability to interpret regulatory guidance (FDA, EMA, ICH, ISPE, etc.)
Knowledge of biologics manufacturing processes
Strong organizational and multitasking abilities
Data integrity and cGMP compliance expertise
Behavioral Competencies
Strong stakeholder management and negotiation skills
Ability to influence and gain support in challenging situations
Effective collaboration across internal and external teams
Leadership Competencies
Set clear goals and expectations for team performance
Provide timely feedback, coaching, and career development
Recruit, train, and motivate validation personnel
Develop effective implementation and contingency plans
Track progress using milestones and KPIs
Commitment to Diversity
Novo Nordisk is an equal opportunity employer. All qualified applicants will be considered without regard to race, ethnicity, religion, gender identity, sexual orientation, disability, veteran status, or other protected characteristics.
Applicants needing accommodation for the application process may contact 1-855-411-5290 (for accommodation requests only).
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