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.

• 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...

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