Microbiology Quality & Sterility Scientist

Johnson & Johnson MedTech; West Chester (Chester County); On-site; USD 76,000 - 122,000; Full time

Benefits offered by this job

Vacation

Sick time

Holiday pay

Parental Leave

Volunteer Leave

Military Spouse Leave

Job summary

Johnson & Johnson, a leader in MedTech, seeks a Microbiology Quality & Sterility Assurance (MQSA) Scientist to lead microbiological quality, sterilization, and reprocessing programs. You will partner with product development and manufacturing to strengthen microbiological controls and ensure patient safety.

Based in West Chester, PA (or other listed U.S. sites), you will apply scientific expertise to advance sterilization strategies and maintain high product quality standards while collaborating

Qualifications

• Minimum 2 years of sterilization/microbiological experience in medical devices, pharma, or food science industries.
• Solid understanding of applicable FDA (QMSR) regulations.
• Experience in microbiology or quality assurance, in production of sterile products.

Responsibilities

• Works with Product Development Teams to ensure microbiological quality requirements are established and met.
• Develops radiation sterilization validations or product adoptions of new products.
• Develops and validates reprocessing instructions or adopts products into existing clinical processing instructions.
• Coordinates the requalification activities for a compliant Ethylene Oxide sterilization program.
• Investigates non-conformances and implements corrective actions with disposition recommendations.
• Prepares and evaluates trending data; monitors out-of-specification results.
• Prepares and routes documents for change request/change order processes.
• Writes standard operating procedures, validation protocols, and validation reports.
• Ensures compliance with GMP/GDP requirements and guidelines.

Skills

Sterilization

Microbiology

FDA regulations

Teamwork

Analytical thinking

Attention to detail

Education

Bachelor's degree in Microbiology

Tools

MS Office

Job description

Johnson & Johnson, a leader in MedTech, seeks a Microbiology Quality & Sterility Assurance (MQSA) Scientist to lead microbiological quality, sterilization, and reprocessing programs. You will partner with product development and manufacturing to strengthen microbiological controls and ensure patient safety.

Based in West Chester, PA (or other listed U.S. sites), you will apply scientific expertise to advance sterilization strategies and maintain high product quality standards while collaborating