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Sterility Assurance Jobs (NOW HIRING)

Kelly Services

Sterility Assurance Lead

Raleigh, NC

$90K - $110K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

The Sterility Assurance Lead is responsible for leading and maintaining site-wide sterility assurance and contamination control programs within a sterile pharmaceutical manufacturing environment.

Novartis

Sterility Assurance Expert

Morris Plains, NJ

$108K - $201K/yr

  • Medical

  • Retirement

  • PTO

As the Sterility Assurance Expert, you will provide handson technical leadership across aseptic processing, microbial control, environmental monitoring, and contamination investigations, ensuring ...

Biosimilar Sciences PR LLC

PR · On-site

Sterility Assurance Lead Location : CII George Sanders Facility, Aguadilla Pueblo, Aguadilla, Puerto Rico 00603 About OcyonBio OcyonBio is a biotechnology company based in Aguadilla, Puerto Rico ...

Novartis

Sterility Assurance Expert

Morris Plains, NJ · On-site

$108K - $201K/yr

  • Medical

  • Retirement

  • PTO

As the Sterility Assurance Expert, you will provide hands-on technical leadership across aseptic processing, microbial control, environmental monitoring, and contamination investigations, ensuring ...

Guerbet

Sterility Assurance Lead

Raleigh, IL · On-site

Sterility Assurance Lead WHAT WE ARE LOOKING FOR Under the direction of the Site Quality Manager, the Sterility Assurance Manager is responsible for leading the site's sterility assurance program ...

Elanco

Sterility Assurance Advisor

Fort Dodge, IA

Sterility Assurance & Contamination Control Strategy As Sterility Assurance & Contamination Control Strategy , you will serve as the site's technical authority for contamination control and sterility ...

Thermo Fisher Scientific

Sterility Assurance Manager

Greenville, NC · On-site

$106K - $128K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

POSITION SUMMARY The Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities for assigned areas of ...

Cardinal Health

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Sterility Assurance Program Leadership: Leading and maintaining the site's Sterility Assurance Program to ensure compliance with cGMP regulations, USP standards, and internal quality requirements

Thermo Fisher Scientific

Sterility Assurance Manager

Greenville, NC · On-site

$106K - $128K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

POSITION SUMMARY The Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities for assigned areas of ...

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How much do sterility assurance jobs pay per hour?

As of Aug 16, 2026, the average hourly pay for sterility assurance in the United States is $44.87, according to ZipRecruiter salary data. Most workers in this role earn between $36.54 and $54.57 per hour, depending on experience, location, and employer.

What is sterility assurance?

A Sterility Assurance job focuses on ensuring that pharmaceutical, medical device, and biotechnology products are free from microbial contamination. Professionals in this role develop, implement, and monitor sterilization processes, environmental controls, and microbial testing programs to comply with regulatory standards. They work closely with manufacturing, quality, and regulatory teams to maintain product safety and efficacy. Their responsibilities also include risk assessments, audits, and validation of sterilization techniques to meet industry guidelines.

What are the typical challenges faced in sterility assurance?

Professionals in Sterility Assurance often encounter challenges such as maintaining strict adherence to regulatory standards, quickly responding to deviations in sterility or contamination events, and ensuring continuous improvement in aseptic practices. The role requires ongoing collaboration with manufacturing, quality, and laboratory teams to troubleshoot issues and implement corrective actions. Additionally, staying up to date with evolving regulatory guidelines and technological advancements is essential for ongoing success. While these challenges can be demanding, they also offer opportunities to develop expertise and advance within the quality and compliance fields.

What skills and qualifications are needed for sterility assurance?

To thrive in Sterility Assurance, you need a solid understanding of microbiology, aseptic techniques, and regulatory compliance, often supported by a degree in life sciences or a related field. Familiarity with sterilization validation methods, environmental monitoring systems, and quality management standards such as ISO and GMP is essential. Strong analytical thinking, problem-solving, and meticulous attention to detail set top performers apart in this role. These competencies are crucial to ensure product safety, regulatory compliance, and the prevention of contamination in pharmaceutical and medical device manufacturing environments.

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Sterility Assurance jobs near you
Infographic showing various Sterility Assurance job openings in the United States as of August 2026, with employment types broken down into 1% Internship, 1% As Needed, 85% Full Time, 9% Part Time, and 4% Contract. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution, with an average salary of $93,338 per year, or $44.9 per hour.

Sterility Assurance Lead

Laboratoire Guerbet

Raleigh, IL • On-site

Full-time

Re-posted 12 days ago

Job description

Sterility Assurance Lead
WHAT WE ARE LOOKING FOR
Under the direction of the Site Quality Manager, the Sterility Assurance Manageris responsible for leading the site's sterility assurance program, ensuring compliance with regulatory requirements, particularly EU Annex 1, and maintaining a robust contamination control strategy (CCS). This role oversees aseptic processing standards, Pre-Autoclave Bioburden control, cleanroom behavior and monitoring, and drives sterility assurance oversight for sterile manufacturing operations. The position supports a culture of quality, risk management, and continuous improvement in sterile product manufacturing.The candidate must have the ability to work with a sense of urgency, assist with maintenance and analysis of Microbiological data, and work with other plant personnel to resolve problems related to actual or potential product quality problems. The candidate will work with, and guide the efforts of Microbiology lab personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with approved SOPs and regulatory documents.
YOUR ROLE
  • Develop, implement, and maintain the site-wide CCS in alignment with Annex 1 and FDA guidance. Lead cross-functional CCS reviews and updates, integrating new risks, CAPAs, and process changes. Provide technical guidance on contamination risks related to personnel, facility, utilities, equipment, and processes.
  • Serve as the site expert on EU GMP Annex 1 requirements. Ensure sterility assurance practices align with current Annex 1 revisions, especially regarding risk-based aseptic practices, environmental monitoring, and CCS. Facilitate readiness and response to regulatory inspections focusing on Annex 1 compliance.
  • Lead sterility risk assessments for aseptic processes, including media fill design and execution. Oversee the environmental and personnel monitoring programs; ensure trending, investigations, and timely responses to excursions. Evaluate and approve change controls, deviations, and CAPAs related to sterile manufacturing operations. Support batch release decisions with sterility assurance assessments, especially for sterility test investigations and atypical results.
  • Ensure control of aseptic gowning, behavior, and personnel qualification programs. Oversee aseptic simulation (media fill) programs to verify operational performance and personnel aseptic technique. Evaluate and maintain effective use and integrity of barrier systems such as isolators, PACs, and HEPA systems.
  • Analyzes and interpret project/study/investigation results and findings. Determines next steps under guidance of the manager and in compliance with applicable regulations; carries out technical and administrative duties as assigned. Responsible for review and approval QC test results as well as logbooks for accuracy and completeness and conformance to SOPs.
  • Provide aseptic behavior and contamination control training to site personnel.Mentor and develop sterility assurance team members and provide subject matter expertise to cross-functional teams.
  • Act as the SME during internal and external audits and inspections regarding aseptic and sterility assurance systems. Proactively identify and address potential compliance gaps

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
  • Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
  • Other duties as assigned with or without accommodation.
  • Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards)

YOUR BACKGROUND
Preferred Skills/ Qualifications:
  • Good interpersonal and verbal/written communication skills; able to use computer for data analysis. Deep knowledge of aseptic processing, cleanroom standards, isolator/PAC technology, EM programs, and sterility test methods.
  • Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements. Self-motivated, energetic, enthusiastic, and team oriented. Strong understanding of EU Annex 1, FDA guidance, and other global GMP standards. Proven experience in risk assessment, contamination control strategies, and regulatory compliance.

Other Skills:
  • Ability to train personnel on various procedures. MS Excel, PowerPoint, Access, and investigation writing. Effective communication with both team members and other plant support groups.

Education and Experience:
  • Bachelor's Degree preferably in Microbiology, Biology or similar life science
  • 7+ years of experience in sterile manufacturing (preferably in pharmaceutical manufacturing), with at least 3 years in a sterility assurance or microbiology leadership role.

Reason to join US
Much more than a Competitive salary,
We offer continued personal development. When you join Guerbet, you :
  • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
  • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,
  • Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.
Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717

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