Sterility Assurance Technician

Orano USA; Brownsburg (IN); On-site; USD 50,000 - 75,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401(k) with employer matching

Generous Paid Time Off

Job summary

Orano USA in Brownsburg, Indiana seeks a Sterility Assurance Technician to ensure compliance with regulatory standards and maintain cleanliness in pharmaceutical manufacturing. The successful candidate will conduct environmental monitoring, collaborate with teams, and assist in microbiology-related investigations.

This role requires a Bachelor's degree in microbiology or related field and two years of experience in the pharmaceutical industry. Excellent collaboration and attention to detail are essential.

Qualifications

• Minimum of two years of experience in the pharmaceutical or biotechnology industry.
• Strong knowledge of FDA regulations and cGMP standards.
• Experience with microbiology laboratory operations.

Responsibilities

• Conduct routine environmental monitoring and testing.
• Assist in root cause analysis for microbiology-related issues.
• Collaborate with teams to resolve quality events.

Skills

Microbiology expertise

Regulatory compliance

Environmental monitoring

Attention to detail

Collaboration skills

Education

Bachelor's degree in microbiology or related field

Job description

Sterility Assurance Technician

Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.

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 manufacturing environments. 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.

Key Responsibilities

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 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 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 and 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 aseptic and sterile operations.
• Foster a culture of quality and compliance within the team.

Qualifications

Education

• Bachelor's degree in microbiology, Biology, Molecular Cellular Biology or related field.

Experience

• Minimum of two (2) years of experience within the pharmaceutical or biotechnology industry.
• 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.

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...

Orano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification from upon hire.

This position requires a pre-employment background check and drug screening.

Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. We ensure that all personnel actions such as recruitment, compensation, career development, benefits, and company-sponsored training are administered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, protected veteran, or other protected status.