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BD (Becton, Dickinson and Company) Quality Sterilization Scientist in Sandy, Utah

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The Quality Sterilization Scientist is responsible for coordinating activities to maintain the sterilization assurance program. This includes sterilization cycle reviews, investigation of out-of-specification results, risk assessments, and protocol authorship/execution. Work with sterilization team to support new product development and validation activities.

The person in this role will provide subject matter expertise to the quality sterility team in support of functions critical to the medical devices. The role is responsible for supporting the validation of new and existing sterilization modalities, fostering improvements to legacy processes, and using critical thinking and analytical reasoning to investigate environmental non-conformances.

Whom we are looking for: Someone with a strong background in microbiology, sterilization, chemistry, or quality engineering and experience demonstrating compliance for medical devices and components. This may include experience in validation, monitoring, ethylene oxide/gamma sterilization, and change management coordination. You have hands-on experience in testing medical devices as well as strong analytical, interpersonal and protocol/report generation skills. You possess the ability to thrive in a multidisciplinary environment supporting the team effort to drive product completion and strive to play an active role in company objectives as well as your own personal growth and development.

JOB DESCRIPTION:

  • Perform analysis of sterilization parameters for product release and sterilization validations.

  • Perform investigation of out-of-specification results.

  • Evaluate historical data to perform risk assessments.

  • Manage EO sterilization requalification and radiation dose audit programs to ensure continuity of validated processes and regulation compliance.

  • Coordinate annual and quarterly process requalification’s and product verifications (Irradiation & Ethylene Oxide).

  • Author, execute, or review protocols to support sterilization goals.

  • Perform routine analysis of EO/ECH residual testing of terminally sterilized medical using gas chromatography (GC-FID).

  • Support routine quality control testing of medical device. This may include: bioburden testing, sterility testing, endotoxin testing, enumeration, and environmental monitoring.

  • Schedules, conducts, documents, and communicates the results of sterilization and microbiology laboratory tests.

  • Ensures that product is tested in a timely manner, minimizing any impacts to production scheduling.

  • Communicates with stakeholders and team members on product or project status.

  • Participate as a member of special project teams, as assigned, including support of sterilization, QC microbiology, R&D and plant objectives.

  • Lead investigations and author reports of results for non-conformance and CAPAs.

  • Maintains metrics within sterilization in order to promote continuous improvement.

  • Assist in training of new employees.

  • Ensures that good housekeeping practices are followed in the area and participates in scheduled lab cleaning and maintenance activities.

  • Ensures that testing and documentation are performed according to GMP and GDP practices.

  • Authors and revises SOPs utilizing an SAP document management system.

  • Support the quality department by performing internal audits.

  • Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations.

  • Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.

  • Other duties as assigned.

JOB REQUIREMENTS:

  • Bachelor’s Degree in STEM highly preferred

  • Two years of experience working in the medical device or pharmaceutical industry or related field.

  • Familiarly with ISO 11135 and ISO 11737

ADDITIONAL AND PREFERRED SKILLS AND QUALIFICATIONS :

  • Experience with Empower, LabWare, and SAP (preferred).

  • Class I / II medical device experience or pharmaceutical experience (preferred)

  • Experience with Process validation(preferred)

  • Understanding of regulatory standards 21CFR, ISO 13485, 11135 11737

PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS:

  • Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.

  • Physical Requirements - Sedentary work: Exerting up to 30 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

  • Visual Acuity - The worker is required to be able to evaluate physicochemical indicator changes and be capable of distinguishing gold/brown from green.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

USA UT - Sandy

Additional Locations

Work Shift

US BD 1st Shift 830am-4pm (United States of America)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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