Sterilization & Microbiology Lead — QA Innovator

DSM Nutritional Products; Exton, Northern (PA, KY); Hybrid; USD 66.000 - 90.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Health and welfare benefits

Growth opportunities

Purpose-led culture

Zusammenfassung

dsm-firmenich in Exton, PA seeks a Lead Specialist, Sterilization and Microbiology to maintain sterilization processes and environmental monitoring for Biomedical products, ensuring microbiological control and safety.

Collaborating with QA/QC and external labs, you will apply ISO13485, FDA guidelines, and cGMP knowledge, while supporting viral inactivation studies and zoonosis reports. Salary ranges reflect market expectations in the region.

Qualifikationen

• Bachelor's degree in Biological science with experience within the medical device/pharmaceutical industry.
• 3-5 years experience in QA/QC, preferably within microbiological control in Medical Device/Pharmaceutical Manufacturing.
• Sterilization experience (gamma, Ebeam, EtO) required.

Aufgaben

• Support sterilization activities and dose audits at the site.
• Manage and maintain internal and sub-contracted testing programs for patient safety.
• Audits of contract facilities using international regulatory standards and ISO 13485.
• Support supplier compliance to sterilization sciences and biosafety standards.
• Review and approve new processes and changes to ensure microbiological control.
• Oversee Environmental Monitoring Program and Controlled Environment qualification activities.
• Support test method validations for lab testing (bioburden, endotoxin).
• Assist NCR disposition in microbiology, sterilization, and product safety functions.
• Perform gap analyses of standards to maintain compliance.
• Support viral inactivation risk assessments and zoonosis reports.

Kenntnisse

Sterilization

QA/QC

Environmental monitoring

Clean room

FDA Regulations

Ausbildung

Bachelor's degree in Biological science

Tools

Microsoft Office

SAP

Document Management Systems

Jobbeschreibung

dsm-firmenich in Exton, PA seeks a Lead Specialist, Sterilization and Microbiology to maintain sterilization processes and environmental monitoring for Biomedical products, ensuring microbiological control and safety.

Collaborating with QA/QC and external labs, you will apply ISO13485, FDA guidelines, and cGMP knowledge, while supporting viral inactivation studies and zoonosis reports. Salary ranges reflect market expectations in the region.