Senior Scientist

Job Description - SENIOR SCIENTIST (2406179852W)
SENIOR SCIENTIST - 2406179852W
Description
Senior Sterility Assurance Scientist At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. 
Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. 
When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough. 
COMPANY
Ethicon Endo-Surgery develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. For more information, visit www.ethiconendosurgery.com
JOB SUMMARY The Senior Sterility Assurance Scientist is responsible for providing expert technical/business
leadership to development teams & operations in areas of end to end contamination control and
sterility assurance policies for the manufacturing of products within Ethicon Endo-Surgery
MedTech MQSA organization.
The Senior Sterility Assurance Scientist technical areas supported include: sterilization
validation (EO and Gamma), reprocessing, microbiological testing to support the validation and
maintenance of the sterilization processes and product label claims (e.g. bioburden, test of
sterility, endotoxin monitoring), environmental control and monitoring, water and air systems
validation, compliance to applicable regulations and standards in the subject areas of s terility
assurance and laboratories.
As applicable evaluate technical & regulatory requirements against business needs in
development & maintenance of corporate level policies, procedures & strategies impacting all
Ethicon Endo-Surgery sterile single use & reusable products, facilities and contractors.
RESPONSIBILITIES: Under limited supervision and in accordance with all applicable federal, state and local
laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
This individual will be responsible for activities such as, but not limited to, the following:
R&D –
1. Collaboration with various groups (R&D, Quality, Operations and Regulatory Affairs) to
ensure manufacturing associated design changes are in compliance to meet
microbiological quality and sterility assurance requirements
2. Support the transfer of new innovative test methods and practices in the areas of
terminal sterilization and industrial microbiology.
3. Work directly with MQSA peers to support development and transfer of break-through
technologies.
4. Work directly with project leaders to define product and sterilization needs for Ethicon
Endo-Surgery products including the validation of those needs.
1. Support operating company in maintaining regulatory readiness
2. Provide support in the development of new manufacturing operations (to include
manufacturing sites and facility investments, contract sterilization & laboratories, and
third party manufacturers).
Source –
1. Provide technical SME support for procurement activities that relate to sterile, non-sterile
or microbiologically controlled products that are externally manufactured.
2. Support requirements for new manufacturing processes, controlled environments and
packaging from a microbiological, terminal sterilization and reprocessing.
3. Provide technical SME support for sterility assurance and contamination control in
Make –
1. Support cross functional compliance to the end-to-end sterility assurance policies at
defined manufacturing facilities.
2. Collaborate with various groups, provide microbiological SME input and support lifecycle
management to ensure product/process changes meet contamination control and sterility
assurance requirements.
3. Support the investigation, gap analysis, and develop corrective action plan for
microbiological or contamination control CAPAs and non-conformance, including root
cause identification and corrective action implementation within agreed timelines (Use
As Is for release of product).
4. Support technical assessments of third-party manufacturers, sterilization contractors,
external laboratories and other applicable suppliers.
6. Work with internal and external laboratories to support sterility assurance testing
requirements (quarterly dose audit samples).
7. Serve as the primary technical liaison for external contract laboratories and external
manufacturers.
Deliver –
1. Ensure all industrial microbiological requirements are compliant to current industry
standards and regulatory requirements.
1. Develop knowledge on best practices in sterility assurance and contamination control by
interacting with JJSA leadership.
1. Interact with product development teams to ensure objectives and project timelines meet
business needs. Interact with peers in sterility assurance to utilize resources and ensure
best practices across facilities.
1. Responsible for communicating business related issues or opportunities to next management
level
2. 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
3. Responsible for ensuring personal and Company compliance with all Federal, State, local and
Company regulations, policies, and procedures
4. Performs other duties assigned as needed
Qualifications
QUALIFICATIONS AND REQUIREMENTS 1. B.S. degree with Microbiology, Biology, Engineering or related scientific/technical discipline is
required (an advanced degree is desirable)
2. A minimum of 4 to 6 years of experience in a medical device industry (terminal sterilization and
industrial microbiology) with a GMP and/or ISO regulated environment is required.
3. Experience with validation of sterilization processes for medical products.
4. Experience in conducting audits of sterilization service providers and ancillary services
5. Personal computer skills, Excel, Word, PowerPoint and analytical software
6. Bilingual (English and Spanish)
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* 1. Qualified candidate will have experience in microbiology, sterilization validation (terminal and/or
reprocessing) and environmental controls for a medical device manufacturing facility.
2. Demonstrated competency in multiple healthcare and industrial terminal sterilization methods
(e.g. EO, Radiation and Moist heat) is required.
3. Ability to troubleshoot process non-conformances and out of specification test results, and
providing resolution to issues by a robust CAPA process
4. Experience in interacting with Regulatory Authorities is preferred
5. Experience with conducting technical assessments of in-house and external manufacturing and
terminal sterilization is preferred.
6. Knowledge of relevant standards EU, USA and ISO is required
7. Oral and written skills and ability to communicate both up and down the business ladder within
franchise or technical competency area is required
8. Demonstrated ability to work in a collaborative/teamwork environment is required
9. Independent organizational and time management skills is required.
10. 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
11. Complete required periodic re-training in areas such as safety & environmental.
12. Training plan requirements as identified in Corporate Training Procedure, CP0128.
13. Must be able to comply with established safety procedures and policies to maintain a safe
working environment to ensure compliance with J&J environmental policies.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor 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.andEqual Employment Opportunity Posters GINA Supplement.
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