Sterility Assurance Expert

Novartis Group Companies; Morris Plains (NJ); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis Group of Companies in Morris Plains, NJ, seeks a Sterility Assurance Expert to lead aseptic processing and microbial control in a regulated biopharmaceutical setting.

You will drive risk-based decisions, manage environmental monitoring, investigations, and regulatory inspections, and partner with Operations, Quality, and Technical teams to strengthen compliance and inspection readiness.

Qualifications

• Bachelor's degree in a scientific or related field.
• 5+ years in sterility assurance within a cGMP-regulated biopharmaceutical environment.
• Experience supporting regulatory inspections (FDA, EMA, MHRA, TGA) in commercial GMP manufacturing.
• Proven leadership of sterility-related investigations, environmental monitoring, and CAPA planning.
• Strong knowledge of global regulatory expectations and data-driven decision making.

Responsibilities

• Serve as site sterility assurance expert for aseptic processing and microbial control programs.
• Design, maintain, and improve sterility assurance strategies aligned with global regulatory expectations.
• Lead sterility-related deviations, contamination investigations, and risk-based decisions.
• Own environmental and personnel monitoring strategies, including trending and escalation.
• Author, review, and approve sterility assurance documentation, validations, and rationales.
• Represent sterility assurance during regulatory inspections, audits, and quality governance forums.
• Partner cross-functionally to resolve sterility risks and strengthen inspection readiness.

Skills

Sterility assurance

Regulatory inspections

Data analysis

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in science

Job description

Job Description Summary

#LI-Onsite

Location: Morris Plains, NJ, United States

Relocation Support: This role is based in Morris Plains, NJ, United States. Novartis is unable to offer relocation support: please only apply if accessible.

This is an opportunity to play a critical role in protecting patients by shaping and defending sterility assurance strategies for advanced aseptic manufacturing. As the Sterility Assurance Expert, you will provide handson technical leadership across aseptic processing, microbial control, environmental monitoring, and contamination investigations, ensuring every decision is scientifically sound, datadriven, and inspectionready. Partnering closely with Operations, Quality, and Technical teams, you will serve as a trusted authority who drives riskbased decisions, strengths compliance with evolving regulatory expectations, and continuously improves sterility assurance programs in a highly regulated, missioncritical environment.

Job Description

Key Responsibilities

• Serve as site sterility assurance expert for aseptic processing and microbial control programs
• Design, maintain, and improve sterility assurance strategies aligned with global regulatory expectations
• Lead sterilityrelated deviations, contamination investigations, and riskbased decision making
• Own environmental and personnel monitoring strategies, including trending, escalation, and continuous improvement
• Author, review, and approve sterility assurance documentation, validations, and technical rationales
• Represent sterility assurance during regulatory inspections, audits, and quality governance forums
• Partner crossfunctionally to resolve sterility risks and strengthen inspection readiness and compliance

Essential Requirements

• Bachelor's degree in a scientific or related technical field
• Extensive experience supporting sterility assurance programs in regulated biopharmaceutical manufacturing environments
• Demonstrated participation in regulatory health authority inspections (e.g., FDA, EMA, MHRA, TGA) within a commercial GMP manufacturing facility, including defense of sterility assurance, aseptic processing, or microbial control programs is required.
• Minimum of five years direct experience supporting commercial aseptic manufacturing operations within a cGMP-regulated environment, including routine production support, deviation management, change control, and real-time risk assessment required.
• Proven experience leading sterilityrelated investigations, environmental monitoring programs, and corrective action planning
• Strong knowledge of global regulatory expectations, including United States and European health authority requirements
• Ability to apply scientific judgment, analyze complex data, and communicate clear, compliant recommendations

Desirable Requirements

• Experience supporting sterility assurance activities for aseptic cell or gene therapy manufacturing is a plus

The pay range for this position at commencement of employment is expected to be between $108,500 and $201,500 per year; however, while salary ranges are effective for a defined period, fluctuations in the job market may necessitate adjustments. Final pay determinations will depend on a variety of factors, including but not limited to geographic location, experience level, knowledge, skills, and abilities. The total compensation package may also include other elements, such as a performancebased bonus and a full range of medical, financial, and other benefits, including retirement programs and paid time off. Details of participation in these benefit plans will be provided if an offer of employment is made. Employment with Novartis is atwill, and the company reserves the right to modify compensation at any time based on individual, business, or market factors.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$108,500.00 - $201,500.00

Skills Desired

Collaboration, Communication Skills (Inactive), Continual Improvement Process, Data Integrity, Digital saviness (Inactive), Leadership, Managing Ambiguity, Problem Solving Skills (Inactive), Regulatory Requirements knowledge (Inactive)