Senior Sterilization Engineer (part-time) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Kymanox · 4 weeks ago

Senior Sterilization Engineer (part-time)

positionMorrisville, North Carolina
timeFull-time, Part-time
remoteOnsite
senioritySenior Level
date7+ years exp

Kymanox is a life sciences professional services company dedicated to delivering high-quality solutions in the biotechnology, pharmaceutical, medical device, and combination product industries. The Senior Sterilization Engineer will collaborate with cross-functional teams to support the development and validation of sterilization and disinfection processes, ensuring compliance with international standards and regulatory guidance.

Life ScienceTechnical Support
check
H1B Sponsor Likelynote

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

Qualification

Sterilization process developmentSterile packaging qualificationISO standards familiarityStatistical software proficiencyProject management skillsCertified Industrial Sterilization SpecialistCommunication skillsProblem-solving skills

Required

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

Preferred

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

Company

Kymanox

twittertwittertwitter
company-logo
Kymanox is a technical products & project management company provides engineering, scientific, regulatory, and process operations support.
dateFounded in 2004
location
Morrisville, North Carolina, USA
people-size201-500 employees
web-link
https://kymanox.com/

H1B Sponsorship

Kymanox has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2020 (2)

Funding

Current Stage
Growth Stage
Total Funding
unknown
2021-08-23Debt Financing
2021-08-02Series Unknown

Leadership Team

leader-logo
Stephen M. Perry
CEO
linkedin
leader-logo
Nicholas Ciccarelli
Chief Technology Officer
linkedin

Recent News

PharmiWeb
Results of Nanoform Collaborative Study to be Presented at the 2025 Partnership Opportunities in Drug Delivery (PODD) Summit
2025-10-21
EIN Presswire
Kymanox® Announces Low Volume Manufacturing Capabilities Supporting Human Clinical Studies
2025-05-08
GlobeNewswire News Room
Silo Pharma Enters Joint Development Agreement for SP-26 Ketamine Implant Device Targeting Pain Management
2024-11-29
Company data provided by crunchbase