Senior Sterilization Engineer (part-time)
Description
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:
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.
Educational Background:
- The ideal candidate will have a bachelor’s degree in engineering or science from an accredited institution.
Experience:
- 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.
Desired Aptitude and Skill Set:
- 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.
Travel:
Up to 10% travel is possible
Compensation:
Pay rate is commensurate with experience, qualifications, and other intangibles evident during the interview process - as well as market conditions.
About Kymanox:
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 project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC.
To learn more about our company, please visit our website: Life Science Solutions | Kymanox
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.