Global Lead, Sterility Assurance Engineer (Medical Devices)

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

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer in Indianola, Pennsylvania, seeks a Staff Engineer for Sterility Assurance to lead sterilization and microbiology efforts across the product lifecycle, ensuring regulatory compliance and robust manufacturing support worldwide.

The role requires a Bachelor's in engineering or science, strong project leadership, and experience with EO and irradiation sterilization, validation, and cross-functional collaboration. Travel up to 20% may be needed.

Qualifications

• Bachelor's degree in engineering or science.
• Experience in medical device manufacturing or sterilization.
• Ability to manage multiple projects with little direction.
• Knowledge of regulatory requirements for sterilization and biocompatibility.

Responsibilities

• Defines requirements to develop and validate sterilization solutions.
• Provides technical leadership across sterilization, microbiology, and safety.
• Plans tests and creates validation plans and reports.
• Creates and reviews SOPs, risk assessments, and change controls.
• Mentors junior staff and collaborates with cross-functional teams.

Skills

Bachelor's degree

Medical devices

Analytical skills

Project management

Leadership

Education

Bachelor's degree

Master of Science degree

Job description

Bayer in Indianola, Pennsylvania, seeks a Staff Engineer for Sterility Assurance to lead sterilization and microbiology efforts across the product lifecycle, ensuring regulatory compliance and robust manufacturing support worldwide.

The role requires a Bachelor's in engineering or science, strong project leadership, and experience with EO and irradiation sterilization, validation, and cross-functional collaboration. Travel up to 20% may be needed.