Sr. Sterilization Scientist
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. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes.
About the role
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 role 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 on innovative sterilization technologies.
Locations: West Chester, PA; Warsaw, IN; Raynham, MA; or Palm Beach Gardens, FL.
Responsibilities
- Effectively communicate and present information on microbiology and cleanliness related to the manufacturing process and/or finished device.
- Work with Product Development Teams to ensure microbiological quality risks are identified and mitigated, and customer/regulatory requirements are met.
- Complete sterilization validations or product adoptions of new products.
- Support compliance audits, including both regulatory and critical supplier audits.
- Conduct technical assessments of contract sterilizers, contract manufacturers, and laboratories.
- Perform investigations to ensure compliance with procedures and regulatory requirements, and verify potential product quality issues are addressed.
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 R&D, Packaging Engineering, Quality Engineering, Regulatory Affairs, Marketing, etc.
- Experience conducting technical assessments of in-house and external manufacturing and terminal sterilization.
- Proficiency 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 English is required.
Preferred Qualifications
- 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), ISO 13485, and ISO 14971.
- Solid understanding of EU, FDA, cGMP, and cGLP regulations.
Pay
The anticipated base pay range for this position is $92,000.00 - $148,350.00.
Benefits
Subject to the terms of their respective plans, 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 (48 hours for Colorado residents, 56 hours for Washington residents)
- 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 period
- Volunteer Leave: 32 hours per calendar year
- Military Spouse Time-Off: 80 hours per calendar year