Sr. Sterilization Scientist

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

Benefits offered by this job

Vacation 120 hours

Sick time 40 hours

Holiday pay

Work Personal and Family Time

Parental Leave

Bereavement Leave

Caregiver Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson MedTech in the United States is seeking a Senior Sterilization Scientist located in West Chester, PA, with responsibilities spanning microbiology, sterilization validation, and cross-functional collaboration with R&D, Quality, Regulatory, and manufacturing teams.

The role requires a Bachelor’s degree in Microbiology or related field and 2–4 years of experience in medical device or pharmaceutical sterilization.

Qualifications

• University/Bachelor’s or equivalent degree in Microbiology, Biomedical Science, Engineering, Food Science or related field is required.
• 2–4 years of related experience in the Medical Device, Pharmaceutical and/or Food Science industries.
• Experience with sterilization/microbiological validations and cross-functional collaboration.

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.

Skills

Sterilization validations

Microbiology knowledge

Cross-functional collaboration

Technical writing

Analytical software

Education

Bachelor's degree in Microbiology/Biomedical Science/Engineering

Tools

Word

Excel

PowerPoint

Adobe

Product lifecycle management

Analytical software

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.

Learn more at https://www.jnj.com/medtech

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

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

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

• 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