Sterilization & Microbiology Lead: Drive Quality & Compliance

dsm-firmenich; Exton (PA); On-site; USD 66,000 - 90,000; Full time

Benefits offered by this job

Competitive pay

Comprehensive benefits

Growth opportunities

Job summary

dsm-firmenich in Exton, PA seeks a Lead Specialist, Sterilization and Microbiology to maintain sterilization activities for Biomedical products and drive microbiological control through the environmental monitoring program. The role partners with QA/QC and supplier labs to ensure regulatory compliance and continuous improvement.

The successful candidate will have a Biological science degree, 3–5 years QA/QC in microbiological control, sterilization experience (gamma, Ebeam, EtO), and knowledge

Qualifications

• Bachelor’s degree in Biological science; medical device/pharma experience preferred.
• 3–5 years QA/QC experience in microbiological control for Medical Device/Pharma manufacturing.
• Sterilization experience with gamma, Ebeam, EtO is required.
• Environmental monitoring experience is a plus.
• Clean room experience is a plus.
• Familiarity with ISO13485 & MDD; ISO 11137 & ISO 11135; FDA 21 CFR 820; GMP.
• Strong knowledge of quality management systems and change management processes.
• Proficiency with Microsoft Office, SAP, and document management systems.

Responsibilities

• Support sterilization activities on site, including dose audits and EO requalification assessments.
• Manage internal and sub-contracted testing programs ensuring patient safety including sterile product release and contamination control.
• Audit contract facilities using ISO 13485 and related standards.
• Support supplier compliance to sterilization science and safety standards; authoring/reviewing validations.
• Review/approve new processes and changes at internal and supplier locations to maintain microbiological control.
• Oversee Environmental Monitoring Program and Controlled Environment qualification activities.
• Support validation of lab test methods (bioburden, endotoxin).
• Assist NCR disposition and correction steps in microbiology, sterilization, and product safety functions.
• Perform gap analyses of applicable standards to maintain compliance.
• Support viral inactivation studies risk assessments and zoonosis reports.

Skills

QA/QC experience

Sterilization experience

Environmental monitoring

Clean room experience

Quality systems

Change management

Microsoft Office

SAP

Document management systems

Education

Bachelor’s degree in Biological science

Tools

SAP

Microsoft Office

Document Management Systems

Job description

dsm-firmenich in Exton, PA seeks a Lead Specialist, Sterilization and Microbiology to maintain sterilization activities for Biomedical products and drive microbiological control through the environmental monitoring program. The role partners with QA/QC and supplier labs to ensure regulatory compliance and continuous improvement.

The successful candidate will have a Biological science degree, 3–5 years QA/QC in microbiological control, sterilization experience (gamma, Ebeam, EtO), and knowledge