Senior Sterilization Engineer; part-time

Senior Sterilization Engineer (part-time)

We are looking for a Senior Sterilization Engineer to work part‑time as a contractor at Kymanox.

Work alongside a cross‑functional team to support our customers in the development and validation of sterilization and disinfection processes.

• 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 conditions.

Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries.

With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and…