SENIOR SCIENTIST MQSA ROBOTICS

Ethicon, part of Johnson and Johnson Med Tech is recruiting for a Senior Scientist MQSA Robotics in Cincinnati, OH.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
nj.
om/.
JOB SUMMARY This position requires translation of product Microbiological and Sterility Assurance (MQSA) quality requirements into RAD (Robotics) product sterility and process improvements.
The position requires an investigative approach by applying strong MQSA principles to deliver effective solutions to achieve regulatory requirements over a broad range of national and international standards.
Responsible for root cause identification as well as implementation of improvements.
Accountable for developing technical solutions to drive improvements in activities such as.
Non-conformances and CAPAs.
Accountable for providing input to the design and validation of reusable device cleaning and disinfection validations and sterilization process validations for new, single use products.
Responsible the E2E MQSA functions supporting marketed sterile single use & reusable medical device products.
DUTIES & RESPONSIBILITIES Under supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position.
1.
Input sterilization validation requirements into team schedules to ensure team goals are met.
2.
Advise teams on microbiological issues related to product design, 3.
Evaluate and ensure compliance to existing and emerging regulatory standards in the areas of device reprocessing, scope reprocessing, cleaning and disinfection of capital equipment and terminal sterilization of devices.
4.
Advise development teams & operations on sterilization validation requirements, appropriate test methods & manufacturing environment to meet quality, cost & release to market objectives.
Strong knowledge of EO sterilization validation and equivalency assessments.
5.
Advise operations (internal & suppliers) on environmental monitoring practices for manufacturing environments.
6.
Determine appropriate DDS strategies for complex product / orientations with possible assistance of more senior level associates.
7.
Trouble-shoot sterilization process deviations & develop short & long term solutions to prevent reoccurrence with possible assistance of more senior level associates.
8.
Advise QS, RA & Product Inquiry on specific sterilization / microbiology questions.
9.
Supervise technical personnel either reporting full time or on temporary assignment to facilitate sterilization validations, troubleshooting or sterilizer operations.
10.
Analyze dosimeter calibration data from internal irradiators & contractors.
11.
Ensure any contractors can meet sterilization policy requirements.
12.
Manage project will be of various size & complexity, but complex projects with high impact to organization will be primary focus.
13.
Perform technical assessments of contract companies related to sterilization & microbiological functions.
14.
Evaluate sterilization related processes.
15.
Set direction and manage sterilization validation testing.
16.
Optimize sterilization operations through development of innovative & cost effective sterilization specifications & procedures.
17.
Responsible for communicating business related issues or opportunities to next management level.
18.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
19.
Performs other duties assigned as needed.
Qualifications EXPERIENCE AND EDUCATION 1.
Bachelor of Science in a Life Science or Chemical Engineering with specific coursework in Microbiology or related field.
2.
7+ years’ experience & demonstrated proficiency in medical device industry (sterilization preferred).
Sufficient experience & training in radiation sterilization, ethylene oxide sterilization & microbiology laboratory procedures to independently resolve sterilization process issues & coordinate appropriate testing.
3.
Ability to work autonomously with minimal guidance needed by a more experienced sterilization scientist on unusual or especially difficult problems.
4.
Demonstrated ability to work effectively in a team environment, 5.
Make effective management level presentations & write formal reports 6.
Training & experience in Good Manufacturing Practices & ISO are also required 7.
English fluent REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS 1.
Knowledge and experience in national/international standards in quality management, sterilization methods, microbiology and sterility assurance.
2.
Maintains working knowledge of relevant standards and compendial methods for sterilization and sterility assurance (e.
.
AAMI, ISO, ASTM, USP/EP/JP, etc.).
3.
Maintains working knowledge of terminal sterilization technologies including radiation, ethylene oxide and moist heat.
4.
Strong written & verbal communication skills 5.
Knowledge of statistical techniques for data management, presentation and analysis 6.
Complete training in area of responsibility within allowed time period.
Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures.
7.
Complete required periodic re-training & assure that required periodic re-training takes place for direct reports in areas such as safety & environmental 8.
Training plan requirements as identified in Corporate Training Procedure, CP OTHER.
· Anticipated salary for this role ranges between $ annually · Travel to support R&D up to 25%.
· Ability to work on site 5 days per week The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits.
Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.
For additional general information on Company benefits, please go to.
https://www.
areers.
nj.
om/employee-benefits This job posting is anticipated to close on April .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.