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12989BR

Title:

Specialist, Product Sterilization (Temporary, 6-8 month contract)

Job Description:

Salary Range

$36.50 - $40.00/hour

Financial compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

Support multiple quality assurance projects and activities to meet the sterilization validation requirements of medical products. Lead sterilization process commissioning, initial sterilization validation and re-validation activities. Provide technical support for sterilization and environmental control activities. Job duties:

+ Conduct revalidations for steam, Ethylene Oxide, and radiation sterilization processes. Work closely with Operations and Quality Engineering teams to coordinate and execute revalidation activities.

+ Conduct technical justifications and physical studies for adoption of new products into existing sterilization cycles, including, but not limited to, sterilization validation, endotoxin level testing (LAL), product bioburden testing, and residual testing.

+ Generate project plans, validation master plans, test protocols, and reports for sterilization validation.

+ Coordinate microbiological testing of validation samples with in-house and outside laboratories.

+ Work with new product development teams on establishing sterilization strategies for steam, radiation, and ethylene oxide sterilization.

+ Support cycle development activities for sterilization processes, including, but not limited to:

+ Determine loading configurations. Determine sterilization cycle parameters based on fractional cycle approach. Identify appropriate PCD configurations, resistance hierarchy, and required quantity for validation.

+ Provide sterilization expertise during interface with regulatory agencies, including FDA and ISO.

+ Support clean room monitoring and validation activities, including, but not limited to, microbial, particulate, and pressure differential testing.

+ Manage sample inventories for real time and accelerated aging studies to support Design Quality/R&D projects.

+ Provide expertise and write-ups to support NCRs and/or CAPAs.

+ Perform other duties as assigned.

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

Auto req ID:

12989BR

Location MV:

Aliso Viejo, California, USA

Department Name:

321-Production Support Quality Assurance

Qualifications:

1. Bachelor’s degree in related field or equivalent.

2. A minimum of four (4) years of related professional experience.

3. Understanding of ISO and FDA requirements for medical product sterilization and for cleanroom monitoring.

4. EN ISO 11135, EN ISO 11137, EN ISO 17665, EN ISO 14644, EN ISO 14698, etc.

5. Working knowledge of various sterilization processes including steam, heat, radiation, ethylene oxide.

6. Experience working with biological indicators (BI’s) and preparing validation samples.

7. Technical writing abilities, including test protocols, reports, and justification documents.

8. Ability to program and extract data from temperature/pressure data loggers.

9. Ability to operate sterilization equipment.

10. Experience working with laboratory testing vendors.

11. Strong written and verbal communication skills.

12. Ability to manage multiple projects simultaneously, stay organized, effectively manage obstacles, and drive projects to completion.

13. Ability to actively collaborate with other departments.

14. Proficient computer skills including MS Word, Excel, Teams, Outlook, and data logging software.

Desired Qualifications

1. Advanced degree in a related field of study.

2. Skills in generating write-ups to support NCRs and/or CAPAs.

3. Advanced degree in related discipline.

4. Certifications in related discipline (ex. CISS).

External-Facing Title:

Specialist, Product Sterilization

Posting Country:

US - United States

Salary Range:

$36.50-$40/hour Financial compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.