Sr. Sterilization Scientist

Johnson Johnson; West Chester (Chester County); On-site; USD 110,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a Sr. Sterilization Scientist to join our MedTech team in West Chester, PA, or adjacent locations.

You will develop and implement sterilization strategies for orthopedic devices, working closely with R&D, Quality, and Regulatory Affairs to ensure product safety and efficacy. The role involves leading sterilization validations, supporting audits, and guiding internal and external partners through complex compliance requirements.

Qualifications

• Bachelor's degree in Microbiology, Biomedical Science, Engineering, or related field.
• 2–4 years in Medical Device, Pharmaceutical, or Food Science industries.
• Experience in sterilization/microbiological validations.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Communicate microbiology and cleanliness topics related to manufacturing and finished devices.
• Collaborate with Product Development to identify microbiological risks and ensure regulatory requirements are met.
• Conduct sterilization validations or adoption of new products.
• Support regulatory and supplier audits.
• Perform assessments of contract sterilizers and laboratories.
• Investigate and ensure compliance with procedures and regulatory requirements.

Skills

Microbiology

Sterilization

Cross-functional collaboration

Quality engineering

Regulatory awareness

Analytical software

Education

Bachelor's degree in Microbiology

Tools

Word

Excel

PowerPoint

Adobe

Product lifecycle management

Job description

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

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.

DePuy Synthes, is recruiting for a Senior Sterilization Scientist , to be located in West Chester, PA; Warsaw, IN; Raynham, MA or Palm Beach Gardens, FL .

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.

As a Sr Sterilization Scientist, you will join our dynamic team of experts in the field of microbiology and sterilization. This position is an opportunity to be a key contributor in the development of end-to-end strategies for the sterile and non-sterile orthopedic medical device portfolio. The position covers the full range of responsibilities for developing, implementing and maintaining sterilization processes to ensure the safety and quality of our products. Your work will contribute to attaining the highest standards of sterilization, preventing contamination, and ensuring product efficacy. While collaborating with a hard-working team of scientists, you will have the opportunity to work with innovative sterilization technologies!

Key Responsibilities:

• Effectively communicate and present information on the topics of microbiology and cleanliness related to the manufacturing process and/or finished device.
• Works with Product Development Teams to ensure the microbiological quality risks are identified & mitigated and customer/regulatory requirements are met.
• Complete sterilization validations or product adoptions of new products.
• Support of compliance audits, including both regulatory and critical supplier audits.
• Conduct technical assessments of contract sterilizers, contract manufacturers and laboratories
• Perform investigations to ensure compliance to procedures and regulatory requirements and verify potential product quality issues are addressed.

Qualifications

Education:

University/Bachelor's or equivalent degree in Microbiology, Biomedical Science, Engineering, Food Science or related field is required.

Experience and Skills:

Required:

• Minimum of two to four (2-4) years of related experience in the Medical Device, Pharmaceutical and/or Food Science industries.
• Experience in sterilization/microbiological validations.
• Strong partnership and communication skills to work effectively on cross-functional project teams, interacting with a diversity of fields such as R & D, Packaging Engineering, Quality Engineering, Regulatory Affairs, Marketing, etc.
• Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization.
• Proficient in computer software such as Word, Excel, PowerPoint, Adobe, product lifecycle management and analytical software.

Preferred:

• Experience writing technical documents, e.g. standard operating procedures, protocols, and test reports.
• Solid understanding of applicable FDA (QMSR) regulations, Canadian Medical Device R