Staff Engineer for Sterility Assurance

Bayer•Indiana Township, PA

1d•$96,480 - $144,720•Onsite

About The Position

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.

Requirements

Bachelor’s degree required (e.g., engineering or science-based degree);
Previous work experience in medical device manufacturing;
Demonstrated knowledge and application of engineering and scientific concepts within medical device;
Effectively manages multiple concurrent projects. Understands priorities of assigned tasks and plans daily activities accordingly. Develops creative solutions to challenging and novel problems under minimal or no direction, exhibiting creativity, foresight, innovation and judgment in anticipating and solving these problems;
Engineering knowledge crossing into multiple technical disciplines. (For Example: Engineering, quality assurance, R&D, regulatory);
Demonstrates analytical capabilities including statistical analysis and problem-solving techniques;
Able to write and apply relevant policies and procedures (P&P) 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;
Approaches challenging situations with an open mind and demonstrates personal drive to discover solutions that are beneficial to the entire project team.

Nice To Haves

Master of Science degree;
7 years minimum work experience in medical device manufacturing, sterilization, microbiology, toxicology, validation, product development, or quality is strongly preferred;
Experience in Ethylene Oxide sterilization process development and validation; adoption of new products to existing processes;
Experience in Radiation sterilization process development and validation (Electron beam, Gamma and x-Ray included); adoption of new products to existing processes;
Demonstrates understanding of biocompatibility and sterilization standards and regulatory requirements for drug products and medical devices. Biocompatibility testing experience and demonstrated familiarity with ISO 10993 and related standards;
Knowledge of material characterization and compatibility with sterilization modalities.

Responsibilities

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 vendor contacts on routine matters;
This role may require international travel (less than 20%) to support global projects;
This role also periodically requires flexing work hours outside of the standard hours in order to support global projects and team members in differing time zones.