Lab Services Sr. 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

Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
Professional

All Job Posting Locations:
San Angelo, Texas, United States of America

Job Description:

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

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for a Lab Services Sr. Scientist to be in San Angelo, TX.

Job Summary

• Lab Services Scientist will report directly to the Lab Services Supervisor/Team Leader and will perform complex tasks related to the Laboratory Instrument Lifecycle and Test Method Validation. This will be done in accordance with laboratory test methods and procedures to provide support in the precise execution of protocols and change management items.
• It is expected that the Services Scientist be capable of serving as an expert in technical areas of instrument troubleshooting and test method science.
• In addition, Services Scientist must possess a sense of responsibility and of property to maintain the calibrated and/or validated state of laboratory instruments an in optimal operating condition.

Duties and Responsibilities

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

• Ensures compliance with Laboratory Instrument Lifecycle and Test Method Validation Franchise procedures
• Coordinates with external suppliers for Lab instrument acquisitions, calibrations, service, and repair
• Able to update, maintain, and populate the Approved Supplier List with the required supplier/vendor categorization and risk assessment
• Documents Audit Observations or CAPA action plans and/or effectiveness monitoring plans
• Write Failure Investigations, Product Impact Assessments to support ETQ nonconformances and/or provided support to product disposition.
• Able to closely work with R&D in support of development, troubleshooting, validation and transfer of test methods to a commercial QA/QC laboratory
• Contributing member of multidisciplinary project teams in the design, development, and manufacturing of surgical sutures and other biosurgical applications.
• Contributing member of project teams in the development and manufacturing of medical devices.
• Plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field.
• Applies comprehensive and diverse knowledge of scientific principles and practices within broad assignment area
• Preparing instrument qualification, method validation and method transfer protocols, execution of protocols and preparation and submission of reports for review and approval.
• Supporting Laboratory Instrument/Software Lifecycle Management
• Using knowledge of scientific techniques to independently troubleshoot instrument issues of a complex nature with a sense of urgency.
• Developing, writing, updating, reviewing & implementation of test methods, SOPs, protocols and specifications as required.
• Providing training for others on test methods, protocols, specifications, laboratory core competencies and SOPs
• Providing audit support (e.g. front room, back room or SME).
• Responsible for communicating business related issues or opportunities to next management level
• 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

• A Bachelor of Science Degree is required.
• Minimum of 6 years of experience with Bachelor of Science Degree performing progressively advanced duties in an Analytical and/or Microbiological Lab setting.
• Must have experience within the medical device industry
• Proven experience in change control process within a regulated industry, including development, implementation and test method validation
• Knowledgeable in ISO, FDA and other regulated standards
• Ability to use Laboratory Software Applications such as Chromatographic Data Systems, Laboratory Execution Systems and Laboratory Information Management Systems.
• Ability to work independently
• Good interpersonal, organizational and oral and written communication skills
• Must be able to interact well with peers and colleagues
• Self-motivated

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.