# Staff Engineer for Sterility Assurance

**Company**: Pharmaceuticals
**Location**: Indianola, Pennsylvania
**Experience**: senior
**Job type**: full-time
**Salary**: $96,480.00 to $144,720.00
**Category**: Engineering
**Industry**: Healthcare

**Apply**: https://talent.bayer.com/careers/job/562949978468635?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_c16602fe-0ab

## Description

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.

## Skills

### Required
- sterilization
- microbiology
- biological safety
- medical device manufacturing
- engineering
- scientific concepts

### Nice to have
- Ethylene Oxide sterilization
- Radiation sterilization
- biocompatibility
- sterilization standards
- regulatory requirements

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Source: [Apply at talent.bayer.com](https://talent.bayer.com/careers/job/562949978468635?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)