Global Lead Engineer, Sterility Assurance

Bayer AG; 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 AG, located in United States : Pennsylvania : Indianola, seeks a Staff Engineer for Sterility Assurance to lead sterilization strategy across NPD and lifecycle sustainment. The role emphasizes technical leadership in EO and irradiation sterilization, process validation, and global regulatory compliance.

The candidate will collaborate with NPD, LCE, operations and suppliers, drive data-driven decisions, and mentor junior scientists and engineers. Travel up to 20% may be required.

Qualifications

• Bachelor's degree in engineering or science field.
• Experience in medical device manufacturing.
• Strong analytical and problem-solving abilities.
• Ability to manage multiple projects and prioritize tasks.
• Ability to write and apply policies and procedures based on regulations.
• Ability to lead teams and coordinate groups to achieve goals.

Responsibilities

• Define project-level requirements to develop, validate and implement sterilization solutions for medical devices and combination products.
• Provide technical leadership in sterilization, microbiology and safety to cross-functional teams.
• Plan and coordinate testing; create validation plans and reports and review supplier activities.
• Lead design and validation efforts for sterilization processes across lifecycle stages.
• Optimize processes for time and cost savings.
• Manage internal/external partnerships and mentor junior staff.

Skills

Bachelor's degree

Medical device manufacturing

Analytical capabilities

Project management

Policy writing

Leadership

Communication

Education

Master of Science degree

Job description

Bayer AG, located in United States : Pennsylvania : Indianola, seeks a Staff Engineer for Sterility Assurance to lead sterilization strategy across NPD and lifecycle sustainment. The role emphasizes technical leadership in EO and irradiation sterilization, process validation, and global regulatory compliance.

The candidate will collaborate with NPD, LCE, operations and suppliers, drive data-driven decisions, and mentor junior scientists and engineers. Travel up to 20% may be required.