STAFF SCIENTIST

Ethicon, part of Johnson and Johnson Med Tech, is recruiting for a  Staff Scientist MQSA in Warsaw, IN.
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 Provide expert technical/business leadership to development teams and Operations in the areas of Microbiological Quality and Sterility Assurance.
Function as an Ethicon, Inc.
technical expert in sterilization and microbiological areas.
Evaluate technical and regulatory requirements against business needs in development and maintenance of corporate level policies, procedures and strategies impacting all Ethicon, Inc sterile, single-use and reusable products, facilities and contractors.
DUTIES & RESPONSIBILITIES The Staff Scientist is responsible for, and has the authority to, perform the following.
Under limited supervision, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position.
Autonomously develops strategies, protocol and project plans for the sterilization of medical devices and biologic products.
Leads the execution of protocols and generates completion reports.
Project management Maintains a safe working environment for self and colleagues and complies with established safety policies and procedures.
Conducts research and contributes to the origination and direction of experiments and new methodologies.
Prioritizes task according to broad project goals.
Supports technical consultants as needed.
Applies scientific principles to new products/technology concepts using creating thinking and innovative techniques.
Designs, develops, and validates new innovative test methods for characterizing medical devices and biomaterials.
Effectively prioritizes and manages multiple activities simultaneously.
Develops test protocols, carries out experiments (including design of equipment/fixtures as needed), analyzes test results, and prepares technical completion reports.
Works with project teams to provide sterilization strategies aimed at supporting product development and regulatory submissions.
Collaborates with associates of diverse technical and non-technical backgrounds to achieve desired project outcomes.
Identifies and mitigates risks associated with new product development activities in area of responsibility.
Develops departmental and/or franchise-level procedures in support of company policies.
Ensures deliverables comply with company and external standards.
Responsible for communicating business related issues or opportunities to next management level.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed Qualifications EXPERIENCE AND EDUCATION* B.
./B.
.
in life science, engineering or related scientific/technical discipline required (e.
.
biology, microbiology, physics, etc.
preferred) MS degree strongly preferred A minimum of ten years direct experience with medical device and/or diagnostic sterilization processes is required with experience at the Senior Scientist/Engineer level or equivalent external experience.
Experience in leading multi-functional project teams for the design and validation of sterilization processes for medical products.
R Experience in conducting audits of sterilization service providers and ancillary services impacting sterilization.
Knowledge in personal computer software (word processing, project planning, presentation, e-mail, flow charts and spreadsheet software) Understanding of information technology in order to allow utilization of new technologies to meet business objectives.
English fluent REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS * Knowledge and experience in national/international standards in quality management, sterilization methods, microbiology, and sterility assurance.
Demonstrated results in Quality Control, Compliance and Regulatory Maintains strong working knowledge of terminal sterilization technologies including radiation, ethylene oxide and moist heat.
Maintains working knowledge of relevant standards and compendial methods for sterilization and sterility assurance (e.
.
AAMI, ISO, ASTM, USP/EP/JP, etc.).
Strategic thinking and big picture orientation Influence Management Strong written and verbal communication skills Knowledge of statistical techniques for data management, presentation, and analysis Customer focus (internal and external) and strong business acumen Results-driven and a sense of urgency Know and follow J&J Med Tech policies and procedures and assure that direct reports (as applicable) know them.
Complete training in area of responsibility within allowed time period.
Training is required for changes in existing policies and procedures, for new assignments and for implementation of new policies and procedures.
Complete required periodic re-training and assure that required periodic re-training takes place for direct reports in areas such as safety and environmental.
OTHER.
·       Anticipated salary for this role ranges between $ annually ·       Travel to support R&D up to 25% (Domestic/International).
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 May .
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.