Sterility Assurance Specialist
- Regular/Permanent
- USA / Indiana
- Telework not possible
Welcome to Orano
Helping to meet current and future challenges to preserve our world and build the world of tomorrow while taking care of everyone's health is stimulating for you. For us too. By joining the Orano Group, a leading international player in the nuclear industry, you are in the right place.
Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.
Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.
Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.
Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.
Job description
The Sterility Assurance Specialist is responsible for maintaining sterility assurance processes and ensuring compliance with industry standards and regulations. They collaborate with cross-functional teams to develop and implement bioburden reduction strategies, perform risk assessments, and address microbiology-related issues.
Key Responsibilities:
Technical Expertise:
- Provide technical expertise in bioburden reduction methods, including aseptic techniques, cleaning, and disinfection practices.
- Be a subject matter expert in sterility assurance in interactions with regulatory bodies (such as the FDA), notified bodies, and customers.
- Develop responses to microbiology and sterilization-related requests and audit findings.
Risk Assessment and Root Cause Analysis:
- Conduct risk assessments related to sterility assurance and microbiology.
- Perform root cause analyses for sterility assurance, environmental monitoring, and other microbiology-related issues.
- Develop corrective and preventive actions to address identified risks.
Compliance and Standards:
- Maintain compliance with relevant regulations (e.g. 21 CFR Part 210/211).
- Ensure adherence to industry standards and best practices.
- Collaborate with internal and external stakeholders to align processes with guidelines.
Quality Control and Audits:
- Regularly audit personnel and processes for bioburden control and sterility assurance.
- Manage and evaluate ISO classification activities, media fills, and gowning validation processes
- Perform trending and analysis of environmental monitoring and other microbiological data for management review and continuous improvement
Team Leadership and Training:
- Provide guidance, training, and support as needed to operators in support of aseptic and sterile operations.
- Foster a culture of quality and compliance within the team.
Our Full-Time Benefits
- Competitive compensation
- Health, Dental, and Vision insurance – with generous employer contributions
- 401(k) with employer matching and contribution amounts
- Life insurance and Short- and Long-Term Disability insurance provided by the company
- Generous Paid Time Off and holiday schedules
- Numerous Training and Development opportunities
- and more…
Ideal qualifications
All candidates should meet the following minimum requirements in order to be considered for this opportunity:
Qualifications:
- Bachelor’s degree in Microbiology or related field (advanced degrees are advantageous).
- Minimum of 2 years of experience in sterility assurance or related roles.
- Strong knowledge of FDA regulations and industry standards.
- Excellent communication and collaboration skills.
Work Environment:
- Work in office and clean room environments
- On site in Brownsburg, IN, with travel up to 10% to Plano, TX
Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.
Orano Med
Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.
Find out more about Orano Med
Find out more about Orano Med
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