Sterilization Scientist

Johnson & Johnson • West Chester, PA

8d • Onsite

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 Sterilization Scientist , located in West Chester, PA; Palm Beach Gardens, FL; Warsaw IN or Raynham, MA. 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 Sterilization Scientist, you will join our dynamic team of experts in the field of sterilization. You will be responsible for 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

• Bachelors or equivalent university degree in Microbiology, Biomedical Science, Engineering, Sterility Assurance, Food Science or related field.
• Minimum of 2 years of sterilization/microbiological experience in the medical device, pharmaceutical and/or food science industries.
• Experience in the field of microbiology or quality assurance, in the production of sterile products.
• MS Office skills
• Strong teamwork and interpersonal skills
• Analytical and critical thinking skills are essential with strict attention to detail.
• Fluency (oral & written) in English is required.

Nice To Haves

• Solid understanding of applicable FDA (QMSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Regulation (MDR), ISO13485, ISO 14971 is strongly preferred.
• Experience writing standard operating procedures, validation protocols, and validation reports.
• Knowledge of EU, FDA, cGMP and cGLP regulations is strongly preferred.

Responsibilities

• Works with Product Development Teams to ensure the microbiological quality requirements are established and met based upon the customer and regulatory needs.
• Investigation of non-conformances, and implementation of corrective actions, and recommend disposition of product.
• Develops radiation sterilization validations or product adoptions of new products.
• Preparation and evaluation of trending data.
• Increases awareness of out of specification (OOS) results.
• Coordinates the requalification activities needed to ensure a compliant Ethylene Oxide (EO) sterilization program.
• Preparation and routing of documents for the change request/change order processes.
• Compliance with GMP/GDP requirements and guidelines.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level