Sterility Assurance Engineer: Global Technical Lead

Bayer; Indianola (PA); On-site; USD 96,000 - 145,000; Full time

Job summary

Bayer in the United States, Pennsylvania, Indianola, seeks a Staff Engineer for Sterility Assurance to lead global sterilization and microbiology activities across the product lifecycle. You will guide development, validation, and maintenance of sterilization processes for medical devices and combination products, ensuring regulatory compliance and manufacturing support.

The role requires a Bachelor’s degree with significant experience in medical device manufacturing, strong analytical and

Qualifications

• Bachelor’s degree in engineering or science-based field.
• Experience in medical device manufacturing.
• Ability to manage multiple concurrent projects and develop creative solutions.

Responsibilities

• Defines project-level requirements to develop and validate sterilization solutions for medical devices and combination products.
• Provides technical leadership in sterilization, microbiology, and biological safety across cross-functional teams.
• Plans and coordinates testing, creates validation plans/reports, reviews validation activities by Bayer and suppliers.
• Designs for sterilization in R&D and in launched product sustainment, troubleshooting globally.
• Optimizes processes to enable time and cost savings.
• Maintains strategic sterilization partnerships and relationships with suppliers.

Skills

Project management

Engineering knowledge

Statistical analysis

Policy writing

Leadership

Problem solving

Communication

Education

Bachelor’s degree

Master of Science (preferred)

Job description

Bayer in the United States, Pennsylvania, Indianola, seeks a Staff Engineer for Sterility Assurance to lead global sterilization and microbiology activities across the product lifecycle. You will guide development, validation, and maintenance of sterilization processes for medical devices and combination products, ensuring regulatory compliance and manufacturing support.

The role requires a Bachelor’s degree with significant experience in medical device manufacturing, strong analytical and