Sterility Assurance Technician

Orano Med is seeking a Sterility Assurance Technician.

The technician will be responsible for conducting routine viable and non-viable environmental monitoring, sampling, and testing. The ideal candidate will collaborate with cross-functional teams to execute bioburden reduction monitoring strategies, evaluation of monitoring data, and assist in identifying and evaluating microbiology-related issues.

Technical Expertise

• Provide support in evaluating bioburden reduction methods, including aseptic techniques, cleaning, and disinfection practices.
• Perform routine environmental monitoring of controlled areas according to established Standard Operating Procedures (SOPs) and protocols.
• Collect and analyze samples for microbial enumeration and identification.
• Maintain proper documentation of all monitoring activities and results in accordance with Good Documentation Practices (GDP).
• Review and draft SOPs on an "as needed" basis.
• Collaborate with cross-functional teams to investigate and resolve quality events, deviations and non-conformances related to environmental monitoring.
• Assist in the validation and qualification of cleanroom facilities and equipment such as Media Fills or facility expansion projects.
• Stay updated on industry regulations and best practices to ensure compliance.
• Ability to confidently interact with regulatory bodies (such as the FDA), notified bodies, and customers.
• Assist in responding to microbiology related requests and audit findings.

Risk Assessment and Root Cause Analysis

• Assist in gathering data and supporting documentation regarding microbiology or sterility assurance related investigations or risk assessments.
• Assist in root cause analyses for sterility assurance, environmental monitoring, and other microbiology-related issues.
• Assist in implementing corrective and preventive actions to address identified root causes and mitigate associated impact/risk assessments.

Compliance & 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 & Audits

• Regularly audit personnel and processes for bioburden control and sterility assurance.

• Manage and evaluate ISO classification activities, media fills, and gowning qualification processes.

• Assist in trending and analysis of environmental monitoring and other microbiological data for management review and identification of continuous improvement opportunities.

Team Membership & Training

• Ability to adjust to unforeseen situations and provide recommendations as needed to achieve operational/business objectives.
• Assist in providing guidance, training, and support as needed to operators in support of 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...

Qualifications Required

Education

• Bachelor's degree in microbiology, Biology, Molecular Cellular Biology or related field.
• Minimum of two (2) years of experience within the pharmaceutical or biotechnology industry.

Experience

• The two (2) years industry experience should be focused on microbiology laboratory experience relating to environmental monitoring, microbiology laboratory operations, sterility assurance or related roles supporting current Good Manufacturing Practices (cGMP).
• Strong knowledge and experience with FDA regulations, United States Pharmacopeia (USP) guidance chapters and International Organization for Standardization (ISO) standards.
• Strong understanding of microbiological testing methods and quality control procedures.
• Excellent attention to detail, communication, organizational, and collaboration skills.

Work Environment

• Ability to work in various settings such as office, warehouse, controlled non-classified (CNC) areas as well as ISO 5, ISO 7 and ISO 8 classified clean room environments.
• Ability to pass and maintain cleanroom gowning qualifications.
• Comfortable with working with radioactive material and strict adherence to proper radiation safety procedures.
• Work on site at the cGMP manufacturing facility located in Brownsburg, Indiana.
• Anticipate 1st shift schedule Monday - Friday (9:00 AM to 5:00 PM) with occasional adjustments in hours due to operational needs and weekend shifts when needed.

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.