Senior Sterilization Engineer (part-time)

Kymanox•Morrisville, NC

10d

About The Position

Position at Kymanox Job Description: I s 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:

Requirements

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
PC skills - MS Office Suite required.

Nice To Haves

Certified Industrial Sterilization Specialist (CISS) a plus
Familiarity with Statistical Process Control (SPC), Lean, Six Sigma knowledge, a plus

Responsibilities

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.