Staff Scientist Microbiology Quality & Sterility Assurance (MQSA), Orthopedics

Johnson & Johnson Innovative Medicine•Warsaw, IN

17d•Hybrid

About The Position

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Johnson & Johnson is recruiting for a Staff Scientist Microbiological Quality & Sterility Assurance (MQSA), located in Raynham, MA or Warsaw, IN. 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 The Microbiological Quality & Sterility Assurance (MQSA), Staff Scientist position is responsible for end-to-end implementation of projects associated with microbiological quality and sterility assurance across the make and product development teams for Orthopedics and will ensure that those programs are aligned with the overall J&J Microbiological Quality & Sterility Assurance programs. The Staff Scientist, MQSA, will serve as a technical leader in the areas of microbiological quality, sterilization, and reprocessing. He/she may manage a team with partners to centrally support end to end microbiological quality. He/she may set the strategic and tactical direction of the team through the application of technical knowledge and expertise in microbiological quality, and sterilization processing. The position will also oversee partnerships for product development, make and the deliver quality organization. This position is responsible for compliance to applicable quality regulations and standards and serves as the site subject matter expert for MQSA.

Requirements

Bachelors or equivalent university degree in Microbiology, Biology, Engineering or related discipline is required.
A minimum of 4-6 years of related experience in a medical device and/or pharmaceutical industry in a GMP and/or ISO regulated environment.
Experience managing a workplace in compliance with regulatory or company requirements.
Ability to communicate science to line management on schedules and processing timetables to ensure timely completion.
Demonstrate strong technical knowledge in microbiological testing and requirements: including cleaning validations, sterilization validations, routine microbiological and chemical contamination control requirements and reprocessing requirements for medical devices.
Experience integrating new technologies and test methods into routine practice.
Conducts technical assessments, evaluates suppliers' other contract services.
Develop innovative ideas for process improvements.
Proficiency in the English language (oral and written) is required.
Up to 10% domestic or international travel is required.
Demonstrates strong people leader and business acumen, this position may have direct reports.

Responsibilities

Subject matter expert expertise on R&D/Scientific Quality and assists in the review of policies that may impact organizational objectives.
Lead the design of new manufacturing processes, controlled environments and packaging for microbiological quality, terminal sterilization and reprocessing.
Assists in the oversight and monitoring of laboratory experiments to test the physical and/or chemical specifications of various substances, materials, and product.
Design systems to collect and test samples and prepare detailed observations to ensure conformity to physical and/or chemical specifications.
Implement processes to ensure the internal organization’s alignment with overall quality priorities.
Help establish formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.
Delivers research related to areas such as microbiology and sterility.
Coaches more junior colleagues in technique, processes, and responsibilities.
Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
Lead J&J MQ&SA as a point of contact or a service leader within operating company supporting new and modified product/process/packaging development and optimization.
Interface with Regulatory Authorities during on-site inspections related to submissions.
Lead MQ&SA remediation activities from audit findings.
Participate as SME in audits internal/external.
Ensure compliance with the team for a safe working environment.
Support integration of new acquisitions relative to MQSA.
Manage processes across multiple quality management systems to support the business.

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year