Sterilization Engineer bei Kymanox
Kymanox · King of Prussia, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in King of Prussia
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.
Responsibilities:
The Sterilization Engineer will work alongside a cross functional team to support our customers in the development and validation of sterilization, disinfection and contamination-control processes. The specialist will direct, advise, and/or execute sterilization, contamination control, and microbiological testing activities through collaborative engagements with clients, sterilization processing and manufacturing sites, and microbiological test labs. The Sterilization Engineer will execute tasks including:
- Analytically assess medical and pharmaceutical products for sterilization feasibility, including determination of most appropriate sterilization method
- Plan, draft protocols, review results, and/or draft reports for microbiological controls, contamination control strategies, and/or bioburden reduction plans/procedures
- Select biological indicators for sterility assurance programs, develop Process Challenge Devices, assess population and/or resistance of challenge microorganisms and/or product bioburden
- Develop sterilization validation plans in conformance with international standards and US/Europe regulatory guidance
- Develop and/or review plans for environmental monitoring (cleanrooms and/or aseptic suites) and review monitoring data, to ensure compliance with regulatory guidance (FDA, EMA, etc.) for terminally sterilized and/or aseptically processed products
- 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
- Establish procedures and documentation for sterilization routine processing
- Work with microbiological test labs to establish/review/revise microbiological test methods and review test results
- 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 interdisciplinary client teams
- Work with and manage external vendors (sterilization processing sites and microbiological test labs)
- Periodically participate in strategic planning activities.
Educational Background:
- The candidate will have a bachelor’s degree in a science-related field such as Engineering, Chemistry, or Microbiology.
Experience:
- Minimum of 5 years of relevant experience in industrial microbiology or sterilization
- Direct experience in process development and/or validation for at least one common contract sterilization methods (such as: EO, gamma/x-ray irradiation, e-beam irradiation)
- Familiarity with ISO standards for sterility assurance, such as ISO 11737, 11138, 17665, 11135, 11137
- Knowledge of microbiological tests, procedures and methods application to contamination control, disinfection and sterilization
- Knowledge of environmental monitoring and aseptic processing requirements and practices
- Knowledge of and experience working within design controls and cGMP manufacturing documentation.
- 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
- Ethical, responsible, and data-driven decision-maker
- Author technical reports and presentations
- Effective communicator of plans, progress, results, and sterilization concepts to internal and client stakeholders
- Flexible and versatile
- Self-directing, self-pacing, fast learner.
- Strong verbal/written communication skills
- Ability to prioritize work spanning multiple projects in a fast-paced, dynamic environment
- Excellent problem-solving skills and results oriented.
- Solid team player
- Familiarity with Statistical Process Control (SPC), Lean, Six Sigma knowledge, a plus
- Follows policies or standard operating procedures to support internal or client projects.
- Completes assigned training requirements (internal and external).
Travel:
Up to 10% travel is anticipated…. A passport is required for this job.
Career Development:
The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.
Compensation:
Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for incentive program after 90 days of outstanding work.
Benefits:
Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.
