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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Johnson & Johnson is recruiting for a Staff Scientist, Microbiological Quality & Sterility Assurance located in Memphis, Tennessee.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.

Microbiological Quality & Sterility Assurance (MQSA), Staff Scientist position is responsible for end-to-end implementation of strategic projects associated with microbiological quality and sterility assurance across the make/deliver 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, Quality Management will serve as a technical leader in the areas of microbiological quality, sterilization, and reprocessing. He/she manages a team with partners to centrally support other product development and product manufacturing teams. He/she sets 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 strategic partnerships for product development, make and direct support for 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.

Key Responsibilities:

• Lead the integration of MQSA policies and procedures at the site.
• Lead the design of new manufacturing processes, controlled environments and packaging for microbiological quality, terminal sterilization and reprocessing.
• Maintain knowledge of best practices, standards and guidance in sterilization, processing, aseptic technique and environmental monitoring. Ensure policies and procedures are maintained to ensure compliance.
• Support all compliance audits, including point of contact for strategic collaborations.
• Manage opportunities for business continuity planning for sterilization and contamination prevention across GO
• Identifies internal and external opportunities to influence best practices in sterility assurance and microbiological quality by interacting with regulators, standard/guideline organizations, research and academic institutions.

Qualifications

Education:

• University/Bachelors or equivalent degree with Microbiology, Biology, Engineering or related discipline is required.

Experience and Skills

Required:

• A minimum of four to six (4-6) years of related experience in a medical device and/or pharmaceutical industry in a GMP and/or ISO regulated environment.
• Competent in using computer software such as Excel, Word and PowerPoint, and analytical software.
• Experience in Microbiology, Sterilization Validation (terminal, aseptic, and/or reprocessing) and Environmental Controls for a medical device or pharmaceutical manufacturing facility.
• Demonstrated capability to lead and train a large and diverse, multinational community with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity.
• Must have a strong understanding of product design, quality and manufacturing processes.
• Proven track record on troubleshooting process, non-conformances, out of specification test results, and providing resolution to issues by a robust CAPA process.
• Experience in interacting with Regulatory Authorities
• Strong knowledge of standards including EU, USA and ISO.
• Strong teamwork and communication skills to work effectively on cross-functional project teams, interacting with a diversity of disciplines such as R & D, Packaging Engineering, Quality Engineering, Regulatory Affairs, Marketing, etc.
• Independent organizational and time management skills.
• Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization.

Other:

• Proficiency in the English language (oral and written) is required.
• Up to 20% domestic or international travel is required.

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.