What are the responsibilities and job description for the Sterility Assurance Specialist position at Kymanox?
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.
Responsibilities
The Sterility Assurance Specialist 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 Sterility Assurance Specialist will execute tasks including:
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.
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, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.
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.
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 Sterility Assurance Specialist 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 Sterility Assurance Specialist 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.
- The candidate will have a bachelor’s degree in a science-related field such as Engineering, Chemistry, or Microbiology.
- 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
- 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).
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.
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, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.
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.
