Principal Sterility Assurance Specialist

Pride Health is seeking a Principal Sterility Assurance Specialist for a healthcare technology company that develops medical products, healthcare software, dental solutions, and biopharma technologies to help improve patient care and healthcare system efficiency.

Job Title: Principal Sterility Assurance Specialist

Location: Eagan, MN

Job Type: Contract

Length: 4-Months

Hours: 40 hours/week

Pay Rate: $55 - $70 per hour

Responsibilities

• Collaborating cross functionally with R&D, regulatory affairs, quality, and internal and external manufacturers to ensure compliance to ISO and FDA requirements for terminally sterilized healthcare products
• Leading and performing sterility assurance activities and deliverables for both marketed products and new product development projects globally per international and US standards such as ISO 11135, ISO 11137, ISO 14698, ISO 11737, ISO 14644 and others as applicable
• Leading as the subject matter expert in a minimum of two sterilization modalities
• Leading and supporting ongoing manufacturing including environmental monitoring and technical leadership for product sterilization requirements
• Providing sterility assurance support during compliance, regulatory and supplier audits
• Providing technical expertise for new product development and change management project teams
• Leading and supporting of timely investigations and root cause analysis related to sterility assurance issues, environmental monitoring excursion events
• Applying working knowledge of ISO standards, sterility assurance and microbiology principles to assigned processes and products
• Authoring and revising of SOPs, WI, templates, etc.
• Leading in new cycle development and strategic sterilization projects
• Coordinating testing with Microbiology labs for bioburden, endotoxin, environmental monitoring, sterility, and EO residuals
• Preparing and analyzing trending data for product bioburden and facility environmental monitoring
• Establishing, leading, and managing major projects to support business initiatives
• Monitoring and maintaining industry standards, including leading in the AAMI standards development committee
• Training of sterility assurance staff in technical concepts and sterility procedures

Qualifications

• Bachelor's Degree or higher
• Eight (8) years of combined experience working in a sterility assurance, quality, engineering, microbiology and/or laboratory/technical function in a private, public, government or military environment

Additional qualifications that could help you succeed even further in this role include:

• Master's degree or higher in Microbiology, Biology, or related discipline from an accredited university
• Minimum 10 years of combined experience working in a sterility assurance, quality, engineering, microbiology and/or laboratory/technical function in a private, public, government or military environment
• Working knowledge of ISO sterilization standards for EO (ISO 11135), Radiation (ISO 11137), ISO cleanrooms (ISO 14644)
• Strong knowledge of Good Manufacturing Practice (cGMP), Good Documentation Practices (GDP), and experience working in an FDA regulated environment
• Strong teamwork and communication skills to work effectively on cross-functional project teams including international teams. Strong technical writing skills for developing sterilization validation protocols and test reports
• Experience with internal and external notified body audits
• Strategic thinking and ability to initiate innovative solutions
• Ability to multi-task and prioritize, strong project management, analytical and problem-solving skills

Benefits that Pride Health offers

Pride Health offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

Apply Today! If you are interested in the position, please email your resume to ***email_hidden*** for immediate consideration.