Senior Microbiology & Product Safety Specialist Exton, PA(Hybrid - on-site 3 days a week)The Senior Microbiology & Product Safety Specialist will support the maintenance of all sterilization activities for dsm-firmenich manufactured products, the execution of site contamination control policies and procedures, providing input to the design of manufacturing processes related to microbiological control, and in producing reports as related to the biosafety of newly developed animal derived products (e.g. viral inactivation studies, zoonosis reports). This role works in partnership with Supplier Quality Assurance team to drive continual improvement in the sterilization processes and services of dsm-firmenich sterilization providers. At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work to not only benefit our People, Customers & Communities but also drive business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.
Key Responsibilities: - Manage and maintain corporate internal and sub-contracted testing programs for assurance of patient safety including sterile product release and contamination control.
- Serve as technical liaison to internal and external laboratory microbiological testing functions including performing audits of the contract facility utilizing international regulatory standards as well as ISO 13485.
- Coordinate supplier compliance to company sterilization sciences and biological safety systems and standards including authoring and reviewing validations and product adoptions into existing processes.
- Assist Regulatory Affairs in the performance of activities related to product evaluation for use in product registration related to microbiological safety.
- Participate in the review and approval of new processes and changes to existing processes both internally and at supplier-based locations to ensure maintenance of microbiological control.
- Oversee the Environmental Monitoring Program and Controlled Environment qualification activities, and implement and maintain adherence to Controlled Environment policies and procedures
- Support/coordinate viral inactivation studies risk assessments as related to viral safety
- Support execution of annual zoonosis reports and literature reviews for animal derived product
We Bring: - A competitive compensation package, with comprehensive health and welfare benefits.
- A place to grow and develop.
- A company that is purpose-led and performance-driven in a corporate culture that values people and planet.
- The opportunity to work on growing brands and build on a strong foundation.
- The chance to make improvements and make an impact on the business.
You Bring: - Bachelor's degree in Biological science.
- 3-5 years' related experience within the medical device/pharmaceutical industry.
- Quality standards ISO13485 & MDD.
- FDA Regulations & Guidelines, 21CFR820, GMP.
- Excellent knowledge of quality management systems.
- Change management/processes.
dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate: there's a place for everyone at dsm-firmenich.As a committed equal opportunity employer, we ensure our recruitment practices are inclusive and fair. We encourage the recruitment of a diverse workforce, representative of the communities in which we work, by using inclusive language, diverse interview panels, diversified sourcing strategies. Selection is based on qualifications, competency, experience, performance history and fit with the team to advance fair and equitable opportunity. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, ethnicity, national origin, religion, gender, gender identity or expression, sexual orientation, age, disability, backgrounds, genetic information, protected veteran status, or any other status protected by law. We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.Please note this is a direct search led by dsm-firmenich. We only accept applications from candidates, not from agencies nor subject to agency's fees, percentages or similar.