Microbiology Quality & Sterility Scientist

Biopharma Careers; West Chester (Chester County); On-site; USD 76,000 - 122,000; Full time

Job summary

Johnson & Johnson is recruiting a Microbiology Quality & Sterility Assurance Scientist in multiple U.S. locations, including West Chester, PA. The role supports DePuy Synthes during corporate separation, ensuring microbiological quality and regulatory compliance across sterile products.

The candidate will develop validations, SOPs, and conduct data trend analyses while adhering to GMP/GDP guidelines. Travel up to 10% may be required, and English fluency is essential.

Qualifications

• Bachelor's degree in Microbiology, Biomedical Science, Engineering, Sterility Assurance, Food Science, or related field.
• Minimum of 2 years of sterilization/microbiological experience in medical device/pharma/food industries.
• Strong understanding of FDA (QMSR) regulations.
• MS Office proficiency.
• Excellent teamwork and communication skills.

Responsibilities

• Works with Product Development Teams to ensure microbiological quality requirements are met per customer/regulatory needs.
• Develops sterilization validations and product adoptions of new products.
• Creates/validates SOPs, validation protocols, and validation reports.
• Coordinates requalification activities for Ethylene Oxide sterilization program.
• Investigates non-conformances and recommends corrective actions with disposition of product.

Skills

Sterilization & microbiology

Teamwork

Analytical thinking

Attention to detail

English proficiency

Education

Bachelor's degree in Microbiology/Biomedical Science

Tools

MS Office

Job description

Johnson & Johnson is recruiting a Microbiology Quality & Sterility Assurance Scientist in multiple U.S. locations, including West Chester, PA. The role supports DePuy Synthes during corporate separation, ensuring microbiological quality and regulatory compliance across sterile products.

The candidate will develop validations, SOPs, and conduct data trend analyses while adhering to GMP/GDP guidelines. Travel up to 10% may be required, and English fluency is essential.