Sterility Assurance Expert
Novartis Group Companies, Morris Plains, NJ, United States
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, strengthens 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 technical field, preferably Microbiology or a related discipline
Extensive experience supporting sterility assurance programs in regulated biopharmaceutical manufacturing environments
Deep understanding of aseptic processing, microbial control strategies, and contamination risk management
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
Direct participation in regulatory inspections with ownership of sterility assurance topics and responses
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.
To learn more about the culture, rewards and benefits we offer our people click here.
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
or call
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, Continuous Improvement mindset, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge
#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, strengthens 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 technical field, preferably Microbiology or a related discipline
Extensive experience supporting sterility assurance programs in regulated biopharmaceutical manufacturing environments
Deep understanding of aseptic processing, microbial control strategies, and contamination risk management
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
Direct participation in regulatory inspections with ownership of sterility assurance topics and responses
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.
To learn more about the culture, rewards and benefits we offer our people click here.
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
or call
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, Continuous Improvement mindset, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge