Staff Scientist

Ethicon, part of Johnson and Johnson Med Tech, is recruiting for a **Staff Scientist MQSA in Warsaw, IN.**

**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.A./B.S. in life science, engineering or related scientific/technical discipline required (e.g. 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.
- 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.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 as