Staff Engineer for Sterility Assurance

At Bayer, we're visionaries driven to solve the world's toughest challenges. As a Staff Engineer for Sterility Assurance, you will serve as a global technical lead for sterilization and microbiology, providing scientific expertise and leadership to support the development, validation, implementation, and maintenance of sterilization processes for medical devices and combination products.

Responsibilities and Tasks:

• Define requirements at the project level to develop, validate, and implement sterilization solutions for combination product and medical device manufacturing operations.
• Provide expertise and technical scientific leadership related to sterilization, microbiology, and biological safety to cross-functional teams.
• Plan and coordinate technical and analytical testing to support sterility assurance.
• Create validation plans and reports and review validation activities performed by Bayer and suppliers.
• Provide technical expertise and scientific leadership across projects with respect to designing for sterilization and launched product/process sustainment.
• Optimize sterilization processes to enable time and cost savings.
• Initiate and maintain strategic sterilization partnerships globally and relationships with key individuals of other organizations.
• Analyze problems and synthesize solutions, exhibiting creativity, foresight, innovation, and judgment in anticipating and solving these problems.
• Create and review plans, reports, SOPs, risk assessments, change controls, design controls, process specifications, sterilization process records, regulatory documents, and supplier audits.
• Plan and manage own work activities of significant technical scope with minimal direction.
• Develop and execute new EO and irradiation sterilization validations.
• Maintain sterilization process validations.
• Respond to health/regulatory authority inquiries related to sterility assurance of combination products and medical devices.
• Serve as SME for sterilization for New Product Development projects.
• Investigate and document sterilization process non-conformances and drive corrective actions.
• Conduct data analysis, trending, and reporting to management.
• Develop and integrate policies and procedures.
• Write technical procedures, test protocols, and reports.
• Mentor and coach junior scientists, engineers, and technicians.

Requirements:

• Bachelor's degree in engineering or science-based degree.
• Previous work experience in medical device manufacturing.
• Demonstrated knowledge and application of engineering and scientific concepts within medical devices.
• Effectively manages multiple concurrent projects.
• Engineering knowledge crossing into multiple technical disciplines.
• Demonstrates analytical capabilities including statistical analysis and problem-solving techniques.
• Able to write and apply relevant policies and procedures based on regulations and industry standards.
• Able to present technical concepts to laypersons and management.
• Demonstrates ability to lead teams and coordinate disparate groups to achieve project goals.

Preferred Qualifications:

• Master's degree.
• 7 years minimum work experience in medical device manufacturing, sterilization, microbiology, toxicology, validation, product development, or quality.
• Experience in Ethylene Oxide sterilization process development and validation.
• Experience in Radiation sterilization process development and validation.
• Demonstrates understanding of biocompatibility and sterilization standards and regulatory requirements for drug products and medical devices.

Benefits:

• Salary between $96,480.00 to $144,720.00.
• Additional compensation may include a bonus or incentive compensation.
• Health care, vision, dental, retirement, PTO, sick leave, etc.