Staff Engineer Sterility Assurance

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us.

If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

This role serves 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. The position works across the product lifecycle, from new product development (NPD) through launched product sustainment (LCE), ensuring compliance with regulatory requirements while supporting manufacturing operations worldwide.

No Sponsorship is available for this position.

• Defines requirements at the project level to develop, validated and implement sterilization solutions applicable to combination product and medical device manufacturing operations;
• Proactively provides expertise and/or technical scientific leadership related to sterilization, microbiology, and biological safety to cross-functional teams including New product development (NPD), Life cycle engineering (LCE), external partners, internal operations, and manufacturing plant staff. Ensures that project deliverables and activities are completed on time with minimal production disruption;
• Plans and coordinates technical and analytical testing to support sterility assurance. Creates validation plans and reports and reviews the validation activities performed by Bayer and suppliers;
• Provides technical expertise and scientific leadership across projects with respect to designing for sterilization (R&D) and launched product/process sustainment (LCE). This includes troubleshooting and root cause analysis for issues related to sterilization processes globally;
• Optimizes sterilization processes to enable time and cost savings;
• Initiates and maintains strategic sterilization partnerships globally and relationships with key individuals of other organizations by providing technical support and co-operation with the suppliers;
• Analyzes problems and synthesizes solutions, exhibiting creativity, foresight, innovation, and judgment in anticipating and solving these problems. Consistently applies complex analytical methods combined to scientific thinking and experimental concepts for solutions supporting data driven decision making;
• Creates and reviews plans, reports, SOPs, risk assessments, change controls, design controls, process specifications, sterilization process records, regulatory documents, third party documents and supplier audits related to the area of responsibility;
• Plans and manages own work activities of significant technical scope with minimal direction;
• Develops and executes new EO and irradiation sterilization validations;
• Maintains sterilization process validations (e.g., quarterly dose audits, annual re-validation of EO sterilization);
• Responds to health/regulatory authority inquiries related to sterility assurance of combination products and medical devices;
• Serves as SME for sterilization for New Product Development projects;
• Investigates and documents sterilization process non-conformances and drives corrective actions in coordination with manufacturing site quality teams;
• Conducts data analysis, trending, and reporting to management;
• Development and integration of policies and procedures (P&P);
• Writes technical procedures, test protocols and reports;
• Seeks new challenges and open to challenge status quo;
• Driven in personal development;
• Promotes knowledge transfer and sharing of best practices;
• Mentors and coaches junior scientists, engineers, and technicians;
• Documents change control activities and related risks assessments;
• Flexible, open to innovative ideas and strategies;
• This role has frequent internal and external company contacts. The incumbent represents the organization on specific projects including new-product development, product lifecycle initiatives, and the overall sterilization network. This role has inter-organizational, outside customer and…