Sr. Sterilization Scientist
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. 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. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech 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!
Requirements
- University/Bachelor’s or equivalent degree in Microbiology, Biomedical Science, Engineering, Food Science or related field is 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.
- Up to 10% domestic travel may be required.
- Fluency (oral & written) in the English language is required.
Nice To Haves
- Experience writing technical documents, e.g. standard operating procedures, protocols, and test reports.
- Solid understanding of applicable FDA (QMSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Regulation (MDR), ISO13485, and ISO 14971 is strongly preferred.
- Solid understanding of EU, FDA, cGMP and cGLP regulations.
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
