Sr. Sterility Assurance Scientist

About the role

The Sterility Assurance Scientist supports activities that maintain compliance to applicable regulations and standards, ensuring the adequacy of activities and documentation in terms of regulatory compliance and technical soundness throughout the manufacturing system. This role works closely with Product Development, Packaging Technology, Regulatory Affairs, Operations, and Quality organizations.

Responsibilities

• Serves as a Subject Matter Expert for Sterilization across the company.
• Maintains and revises procedures and methodologies to cover sterilization programs across sites.
• Obtains and maintains knowledge of FDA, ISO, and EN sterilization and related microbiology standards and guidelines.
• Supports EU MDR compliance by performing gap analysis and formulating gap resolution plans.
• Subject matter expert with regard to technical assessments of contract sterilizers and laboratories.
• Makes sure contamination control measures are adequate at external suppliers.
• Provides training to procedural changes.
• Provides guidance and input on the resolution of sterility related non-conformances.
• Supports sterilization validations, cleaning validations, and supporting activities for all product families by setting company policy and direction for these activities.
• Works with product development to ensure timely and complete sterilization adoptions and validations of all new products including the introduction of new novel sterilization processes.
• Trains Product Development personnel in contamination control and sterilization requirements and procedures.
• Collaborates with Subject Matter Experts from other departments to ensure a comprehensive approach to bringing new and changed products into production.
• Assists sites as an expert consultant in sterile release, bioburden and dose audit, and environmental monitoring programs as necessary.
• Creates and finalizes validation protocols and reports ensuring they are clear, concise, and compliant to work instructions and standards.
• Knows and follows all laws and policies that apply to the position, and maintains the highest level of professionalism, ethics, and compliance always.
• Participates in audits and other compliance program-related activities.
• Executes other duties/responsibilities as assigned by manager.

Requirements

• A minimum of a Bachelor Degree is required. A Bachelor Degree in Microbiology, Biological Sciences or Engineering is preferred.
• Experience related to manufacturing and contamination control is preferred.
• Experience in sterilization/microbiology, medical device, Pharmaceutical and or / food industry is required.
• 10+ years of experience working with sterilization of medical devices or pharmaceuticals.
• Have working knowledge of ISO documents related to sterilization such as ISO 11135 and 11137.
• Familiar with government regulations and Industry guidelines for sterilization and microbiological control.
• Working knowledge of applicable software, particularly Microsoft Office applications is required.
• Strong collaboration and communication skills needed to effectively work on cross-functional teams, interacting with a diversity of disciplines and locations.
• Experience writing standard operating procedures, protocols, and test reports is preferred.
• Basic understanding of microbiology, chemistry and engineering.
• Strict attention to detail.
• Must be able to work under pressure due to reporting deadlines.
• Must be able to work with limited supervision.
• Strong written and oral communication and interpersonal (listening) skills.
• Familiarity with basic quality tools and techniques.
• Analytical and critical thinking skills are important.
• Excellent organizational and time management skills.
• Willing to work in an international team.
• Ability to travel 25%.

Qualifications

• Salary Range: $81,650.00 - $112,700.00 USD
• Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
• Equal Opportunity Employer: We are committed to providing qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA.

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• Short- and Long-Term Disability
• Business Accident Insurance
• Group Legal Insurance
• Savings Plan (401(k))

Pay

Pay Range: $81,650.00 - $112,700.00 USD

Schedule

Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.