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Sterility Assurance Jobs (NOW HIRING)

Orano

Sterility Assurance Technician

Brownsburg, IN · On-site

General Information Name Sterility Assurance Technician Ref # 14958 Posting Date Tuesday, June 23, 2026 Country United States Region Indiana City Brownsburg (IN) Business Unit (BU) CORP Type of ...

Orano

Sterility Assurance Technician

Brownsburg, IN · On-site

We are seeking a detail-oriented Sterility Assurance Technician with expertise in microbiology to ensure compliance with regulatory standards and maintain cleanliness in the Orano Med pharmaceutical ...

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How much do sterility assurance jobs pay per hour?

As of Aug 17, 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 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.

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.

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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.

Global Sterility Assurance Systems & Standards Lead

CSL

Bradley, IL

Full-time

Posted 5 days ago

Job description

Global Sterility Assurance Systems & Standards Lead

Reporting to the Head of Global Sterility Assurance, this strategic position sits in the Global Quality Operations organisation. Ensuring the quality, safety and reliable supply of our products' pipeline is critical. This newly created leadership role executes Sterility Assurance oversight and support to CSL sites and CMOs to ensure that sites operate in compliance to the highest standard regulatory expectations.

By driving sterility assurance across partnering functions, this position ensures consistent standards, proactive risk management, and global inspection readiness.

Responsibilities:

  • Provide strategic leadership to the site related to sterility assurance standards, culture and continuous improvement
  • Perform effective regulatory and business intelligence about sterile manufacturing and Sterility Assurance
  • Work collaboratively with the global sterility assurance teams to provide a holistic microbial contamination control strategy and improvement plan at the site
  • Partner closely with the global function leads as well as site leadership team, develop strategies to ensure continuous adherence to regulatory and CSL standards related to sterility assurance governance and drive improvements
  • Provide expert input to Sterility Assurance related major deviation investigations in the area of sterile filtration, aseptic filling and lyophilization and sterility, media fill and bioburden test fail
  • Proactively work with sites and global stakeholders on inspection readiness for the sites (before, during and after inspections)
  • Provide CMOs and filling strategies Sterility Support (CMO selection process, technologies intelligence )
  • Provide strong Sterility Assurance background and support on strategic CSL projects (i.e. new filling lines selection and design)
  • Develop and lead Sterility Assurance Roadmaps for compliance and performance
  • Ensure appropriate development, implementation and maintenance of sterility assurance standards and processes consistent with global governance, regulatory requirements and industry standards.
  • Align and facilitate collaboration across Technical Operations, Quality functions, Operations, and R&D, to successfully drive aseptic excellence

Qualifications:

  • Bachelor's degree in microbiology or biology or life sciences or equivalent relevant field
  • 8-10 years' experience in pharmaceutical manufacturing industry with direct experience executing quality assurance within a manufacturing and QC microbiology, sterility assurance context
  • Demonstrated experience in quality assurance and regulation compliance with GxP, FDA, EU and other regulatory agency guidelines
  • Experience interacting with regulatory authorities including submissions and inspections; knowledge of auditing practices and procedure

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Commonwealth Serum Laboratories logo

About Commonwealth Serum Laboratories

Sourced by ZipRecruiter

Commonwealth Serum Laboratories (CSL) is a global leader in biotechnology, based in King of Prussia, Pennsylvania. The company originates from Australia, founded in 1916 by the Australian government to service the country’s health needs. Since then, CSL has expanded operations to become a multinational specialty biotechnology company that researches, develops, and manufactures vaccines and plasma protein biotherapies. Their mission is underpinned by focused, patient-driven values. Our commitment to saving lives and protecting people's health by providing safe and effective products is a testament to the difference we are making. One of their considerate achievements includes establishing one of the largest influenza vaccine providers in the world through their brand Seqirus.

Industry

Scientific research and development services

Company size

10,000+ Employees

Headquarters location

King of Prussia, PA, US

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