Sr. Sterilization Scientist

Johnson & Johnson MedTech; West Chester (Chester County); On-site; USD 92,000 - 148,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Senior Sterilization Scientist to be located in West Chester, PA, or other MedTech sites. The role involves developing and maintaining sterilization processes, collaborating with R&D, QA and Manufacturing to ensure safety and quality of orthopedic devices.

The candidate should have 2–4 years in sterilization/microbiology, strong cross-functional communication, and familiarity with FDA/regulatory expectations. Domestic travel up to 10% may be required.

Qualifications

• Bachelor’s or equivalent in Microbiology, Biomedical Science, Engineering or related field.
• 2–4 years in Medical Device, Pharmaceutical or Food Science industries.
• Experience with sterilization/microbiological validations.
• Strong cross-functional collaboration and communication skills.
• Proficient in Word, Excel, PowerPoint, Adobe and PLM software.

Responsibilities

• Communicate microbiology and cleanliness topics for manufacturing.
• Work with Product Dev teams to identify microbiological quality risks.
• Complete sterilization validations or product adoptions.
• Support compliance audits (regulatory and supplier).
• Conduct technical assessments of contract sterilizers and labs.
• Investigate issues to ensure regulatory compliance and product quality.

Skills

Sterilization experience

Microbiology background

Cross-functional collaboration

Software proficiency (MS Office, PLM)

Education

Bachelor’s degree in Microbiology or related field

Tools

Word

Excel

PowerPoint

Adobe

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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!

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.

Required

Experience and Skills:

• 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 Regulation (CMDR), Medical Device Regulation (MDR), ISO13485, and ISO 14971 is strongly preferred.
• Solid understanding of EU, FDA, cGMP and cGLP regulations.

Other

• Up to 10% domestic travel may be required.
• Fluency (oral & written) in the English language 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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills

Preferred Skills: Agility Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

The anticipated base pay range for this position is :

$92,000.00 - $148,350.00

Additional Description For Pay Transparency

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)).

Benefits

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits