Senior Microbiology & ProductSafety Specialist
Exton, PA
(Hybrid - on-site 3 days a week)
The Senior Microbiology & ProductSafety Specialistwill supportthe maintenance of all sterilization activities for dsm-firmenich manufactured products, the execution of site contamination control policies and procedures, providing inputtothe design of manufacturing processes relatedto microbiologicalcontrol, and in producing reports as relatedtothe biosafety of newly developed animal derived products (e.g. viral inactivation studies, zoonosis reports). This role works in partnershipwith Supplier Quality Assuranceteamto drive continual improvementinthe 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-contractedtesting programs for assurance of patientsafety including sterile productrelease and contaminationcontrol.
Serve astechnical liaisonto internal and external laboratory microbiologicaltesting functions including performing audits ofthe contractfacility utilizing international regulatory standards as well as ISO 13485.
Coordinate supplier complianceto company sterilization sciences and biological safety systems and standards including authoring and reviewing validations and productadoptions into existing processes.
AssistRegulatory Affairs inthe performance of activities relatedto productevaluation for use in productregistration relatedto microbiological safety.
Participate inthe review and approval of new processes and changesto existing processes both internally and atsupplier-based locationstoensure maintenance of microbiological control.
Overseethe Environmental Monitoring Program andControlled Environmentqualification activities, and implementand maintain adherenceto Controlled Environmentpolicies and procedures
Support/coordinate viral inactivation studies risk assessments as relatedto viral safety
Supportexecution 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'sdegree in Biologicalscience.
3-5 years' related experience withinthe medical device/pharmaceutical industry.
Quality standards ISO13485 & MDD.
FDA Regulations & Guidelines, 21CFR820, GMP.
Excellent knowledge of quality managementsystems.
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.