Staff Scientist

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.jnj.com

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About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Staff Scientist to be in Ciudad Juárez, Ethicon INC.

Purpose:

• Providing expert technical / business leadership to development teams & operations in the areas of Microbiological Quality and Sterilization.
• Functioning as a technical expert in sterilization & microbiological areas. This may include representing Operating Company or Functional Support area and/or J&J at industry wide conferences and committees.
• Proactively evaluating technical & regulatory requirements against business needs to assure compliance and to develop innovative & cost effective policies, procedures & strategies impacting all ETHICON Company sterile products, facilities & contractors.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Develop 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.
• Provide support to Operating Companies in investigating process non-conformances, assisting in identifying root cause, and developing robust CAPA.
• Lead/support MQ&SA audits for contractors or external suppliers.
• Ability to deal with ambiguity and demonstrate adaptability.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.
• Responsible for communicating business related issues or opportunities to next management level o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• 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 / Requirements:

EDUCATION

• B.A./B.S. in life science, engineering or related scientific/technical discipline required (e.g. biology, microbiology, physics, etc.)
• MS degree strongly preferred

JOB EXPERIENCE

• 10+ 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.

LEVEL OF RESPONSIBILITY

• 1. Experience in leading multi-functional project teams for the design and validation of sterilization processes for medical products.
• 2. Experience in conducting audits of sterilization service providers and ancillary services impacting sterilization.
• 3. Knowledge in personal computer software (word processing, project planning, presentation, e-mail, flow charts and spreadsheet software).
• 4. Understanding of information technology in order to allow utilization of new technologies to meet business objectives.
• 5. 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.g. 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.