Staff Sterility Assurance Specialist

Terumo•Elkton, MD

About The Position

The Staff Sterility Assurance Specialist is a technical leader on the Sterility Assurance team, responsible for independently leading critical sterility assurance projects and initiatives. This role solves complex problems, including cross-site troubleshooting, and serves as a mentor and subject matter expert (SME) for the Sterility Assurance function (industrial microbiology and sterilization – ethylene oxide, gamma radiation, and moist heat). The Staff Specialist partners closely with Operations, Quality, Laboratory Operations, Engineering/PMO, and Regulatory Affairs, as well as external and internal sterilization partners, to ensure compliant, efficient, and robust sterilization processes and strategies that enable business operational directives. This role provides technical leadership on key business initiatives, and strengthens Sterility Assurance organizational capability through mentorship and cross-functional influence.

Requirements

Bachelor’s degree in Microbiology, Molecular Biology, Biomedical Engineering, or related scientific field.
Requires 9 – 12 years of experience in sterility assurance, with focus on ethylene oxide and gamma sterilization and industrial microbiology. Candidates with prior supervisory, team-lead, or mentoring responsibilities within these technical areas may qualify with experience at the lower end of the range.
Strong technical writing skills with demonstrated experience in authoring scientific protocols, reports, investigations, risk assessments, etc.
Expertise in standards and regulations governing EO and gamma sterilization modalities (e.g., ISO 11135, ISO 11137 series, ISO 11138 series, etc.) and microbiological principles (e.g., ISO 11737 series, ANSI ST72, ISO 14644 series, etc.).
Experience supporting audits and working within a regulated environment (FDA, ISO, etc.).
Proficiency in data analysis tools (e.g., Excel, Minitab) and statistical interpretation.
High degree of scientific and analytical rigor, critical thinking
Strong independent decision-making aligned with regulatory and technical requirements
Attention to detail and documentation accuracy
Cross-functional collaboration
Effective communication (written and verbal)

Nice To Haves

Supervisory and/or leadership experience strongly preferred
Experience with moist heat sterilization (ISO 17665) and/or vaporized hydrogen peroxide (ISO 22441)
Experience with quality engineering tools (e.g., FMEA, CAPA, root cause analysis).
Familiarity with regulatory submission processes (e.g., 510(k), PMA).

Responsibilities

Develop, author, and review technical protocols and reports related to microbiological testing, environmental monitoring, and sterilization validations, including product/process adoptions and change control.
Analyze and interpret complex data sets from microbiology and/or sterilization studies to support trend analysis, annual reviews, program optimization activities, and technical projects. Provide recommendations and strategies for continuous improvement.
Collaborate with cross-functional teams including Quality, Regulatory, Engineering/PMO, and Operations to ensure alignment on technical direction, strategy, and project timelines, as applicable. Provides technical leadership to new product development and design change/change control projects.
Support internal and external audits by preparing documentation, responding to observations, and participating in audit readiness activities. Represent Sterility Assurance in audit activities as needed.
Apply quality engineering principles to assess risk, drive continuous improvement, and ensure compliance with applicable technical standards (e.g., ISO 14644, ISO 11737, ISO 11135, ISO 11137, etc.).
Lead triage and resolution of complex technical issues spanning sterilization/microbiology process performance. Conduct and/or oversee root cause investigations and manage nonconformances and CAPAs related to the areas of microbiology and sterilization.
Serve as a technical leader of the Sterility Assurance team. Mentor and coach Sterility Assurance team members. Uplift technical capability and documentation quality.
Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.