Senior Sterilization Engineer; part-time

Job Description

Is Kymanox the right fit for you? You want to make a difference and have an impact… You enjoy having an influence in your day‑to‑day work… You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow… You wake up every day and do what you do… because patients deserve better. If this sounds like you, you’ve come to the right place.

The Senior Sterilization Engineer (Contract) will work alongside a cross‑functional team to support our customers in the development and validation of sterilization and disinfection processes. This engineer will direct, advise, and/or execute sterilization process development and qualification activities through collaborative engagements with clients, sterilization processing sites, and microbiological test labs. The Senior Sterilization Engineer (Contract) will execute tasks that may include:

• Analytically assess medical and pharmaceutical products for sterilization feasibility, including determination of most appropriate sterilization mode & method.
• Develop sterilization validation plans in conformance with international standards and US/Europe regulatory guidance.
• Plan, draft protocols, review results, and/or draft reports for sterilization process definition and/or process optimization studies.
• Plan, draft protocols, review results, and/or draft/review reports for sterilization validations under IQ/OQ/PQ framework in conformance with international standards and US/Europe regulatory guidance.
• Assess material compatibility, either analytically or experimentally, for sterilization processes.
• Establish procedures and documentation for sterilization routine processing.
• Work with microbiological test labs to establish/review/revise microbiological test methods and review test results.
• Select and/or design sterile packaging for products.
• Plan, draft protocols, review results, and/or draft/review reports for sterile packaging qualification and sterility maintenance verification.
• Perform analytical assessments to inform design directions as needed.
• Work with cross‑functional teams within the organization and with clients and external vendors (sterilization processing sites and microbiological test labs).
• Periodically participate in strategic planning activities.

• The ideal candidate will have a bachelor’s degree in engineering or science from an accredited institution.

• Minimum of 7 years of relevant experience in sterilization, sterile packaging and/or microbiology
• Direct experience in new process development and validation for at least two of common sterilization methods (such as: EO, gamma/x-ray irradiation, e-beam irradiation, steam heat, dry heat, hydrogen peroxide, etc.)
• Detailed familiarity with key ISO standards for sterilization, such as ISO 11135, 11137, 17665, 14937
• Strong leadership and project management skills with proven track record within testing and validation.
• Knowledge of design controls.
• Proficiency utilizing MS Office Suite (Word, PowerPoint and Excel etc.), and statistical software tools such as Minitab for data analysis or experiment design.

• Ability to translate sterilization ISO standards and regulatory guidance into specific procedures and tests for a range of medical and pharmaceutical products
• Independent contributor, able to drive the sterilization scope of a project with minimal oversight
• Ethical, responsible, and data-driven decision-maker
• Flexible and versatile
• Self-directing, self-pacing, fast learner.
• Strong verbal/written communication skills
• Adept at communicating progress, challenges and results to non-expert stakeholders
• Ability to prioritize work in a fast‑paced, dynamic environment
• Excellent problem‑solving skills and results oriented
• Solid team player
• Certified Industrial Sterilization Specialist (CISS) a plus
• Familiarity with Statistical Process Control (SPC), Lean, Six Sigma knowledge, a plus
• PC skills - MS Office Suite required.

Up to 10% travel is possible

Pay rate is commensurate with experience, qualifications, and other intangibles evident during the interview process - as well as market…