Job Description SummarySupports the Quality Assurance Laboratory by performing a variety of tests as part of product release and the sterilization assurance program. As assigned, performs environment monitoring in classified GMP manufacturing areas, executes protocols in an EO sterilizer staging area and tests for organisms in a lab or cleanroom setting. Supports these activities with appropriate documentation following GDP.Job DescriptionWe are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
Maintains the cleanliness and orderliness of laboratory glassware.
Performs verification of lab equipment.
Maintains and distributes chemicals and supplies.
Maintains materials’ inventory.
Conducts monthly inspections of laboratory safety equipment.
Complies with regulations as outlined in GMPs.
Disposes of laboratory waste.
Aseptically and safely works with live organisms and cultures
Performs basic microbiological testing on raw materials and finished goods to ensure compliance to specifications.
Works inside varying ISO classifications of cleanrooms, including those with active manufacturing, to perform testing
Perform routine analysis of EO/ECH residual testing of terminally sterilized medical using gas chromatography (GC-FID).
Conducts investigations in a timely manner.
Writes technical reports.
Writes and updates standard operating procedures and laboratory documents/forms.
Work overtime as needed by the department. Work flexible hours as business needs require.
Communicate in an effective, timely, and appropriate manner to all associates (i.e. peers, support teams and management) including escalating issues.
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.
This is not intended to be an all-inclusive listing of duties. Other job-related duties may be required.
Education and Experience:
This position requires:
Two years relevant experience working in a laboratory environmentor equivalent experience
Experience with ISO and USP standards
Understanding of GLP, GMP, and GDP
Preferred qualifications include:
BS Degree in Microbiology/related STEM Degree
Knowledge of basic Microbiological or EO Sterilization terminology
Pharmaceutical and/or Medical Device experience
Experience in a manufacturing environment
Experience working withBioburden BI’s, PCD’s, EO Residuals, Endotoxins and/or Environmental monitoringand other Microbial related testing
Experience with Labware, Empower and SAP
Knowledge and Skills:
Critical Knowledge and Skill to perform and deliver to the scope and deliverables of the job.
Working knowledge of metric system
Ability to Interpret drawings and specifications
Effective written and oral communication skills (English), math skills, and interpersonal skills
Basic computer skills
Physical Demands:While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.Work Environment:
This position is in a clean room or laboratory manufacturing environment and the physical demands described are representative of those that must be met by an incumbent to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions (Per the Americans with Disabilities Act of 1990)
The incumbent may be frequentlyrequired to stand and/or occasionally sit for extended periods of time. Bending, stooping and reaching are also frequentlyrequired. While performing this job, the employee is regularly exposed to episodes of walking, kneeling, balancing, crouching, pushing/pulling, repetitive grasping, hearing, twisting, lifting, frequent use of hand to finger, handle, feel, pick or type which can include repetitive motion of the wrists, hands or fingers.
The position will have some exposure to work near moving mechanical equipment, and potential temperature fluctuations.
Occasionally the position will have exposure to fumes, airborne particles, hazardous chemicals, cleaning compounds and solvents.
The incumbent may be exposed to noise levels in the work environment moderate to loud.
The incumbent must be willing and able to wear required PPE such as, safety glasses, face mask and/or shield, hearing protection, safety shoes, hair and beard net and smock.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.To learn more about BD visit https://bd.com/careersBecton, 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 LocationUSA UT - SandyAdditional LocationsWork ShiftUS BD 1st Shift 8am-430pm (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.