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

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As a Senior 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 responsibility 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.

• Must have a strong understanding of product design, quality and manufacturing processes.

• Experience with conducting manufacturing and terminal sterilization technical assessments.

• Experience in interacting with Regulatory Authorities

• Independent organizational and time management skills.

• 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 (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Regulation (MDR), ISO13485, and ISO 14971 is strongly preferred.

Other:

• Up to 10% domestic travel may be required.

• Fluency (oral & written) in the English language is required.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.