Sterilization & Microbiology Lead - QA & Process Improvement

DSM-Firmenich AG; Exton, Northern (PA, KY); Hybrid; USD 66,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Grow and develop

Purpose-driven culture

Work on growing brands

Make an impact

Job summary

The Lead Specialist, Sterilization and Microbiology at dsm-firmenich in Exton, PA will support maintenance of sterilization activities for Biomedical products, manage environmental monitoring, and contribute to microbiological control design and reporting.

You will partner with Supplier Quality Assurance to drive continuous improvement, perform audits of contract facilities, and ensure compliance with ISO13485, ISO11137/11135, 21 CFR 820 and GMP.

Qualifications

• Bachelor’s degree in Biological science with medical device/pharmaceutical industry exposure.
• 3–5 years in QA/QC, especially in microbiological control in Medical Device/Pharmaceutical Manufacturing.
• Sterilization experience (gamma, Ebeam, EtO) required.
• Familiarity with ISO13485, MDD, ISO11137, ISO11135 and FDA GMP guidelines.
• Strong knowledge of quality management systems and change control processes.

Responsibilities

• Support sterilization activities on site products, including dose audits and EO requalification.
• Manage internal and subcontracted testing programs for patient safety and sterile release.
• Audit contract facilities and ensure regulatory compliance for microbiology testing.
• Support supplier compliance to sterilization and biosafety standards, including validations.
• Oversee Environmental Monitoring and Cleanroom/Controlled Environment topics.
• Perform test method validations for lab testing such as bioburden or endotoxin.
• Assist NCR disposition and corrections in microbiology, sterilization, and product safety.
• Contribute to viral inactivation risk assessments and zoonosis reports.

Skills

QA/QC experience

Sterilization knowledge

Regulatory compliance

Statistical knowledge

Change management

MS Office

Education

Bachelor’s degree in Biological science

Tools

Microsoft Office

SAP

Document Management Systems

Job description

The Lead Specialist, Sterilization and Microbiology at dsm-firmenich in Exton, PA will support maintenance of sterilization activities for Biomedical products, manage environmental monitoring, and contribute to microbiological control design and reporting.

You will partner with Supplier Quality Assurance to drive continuous improvement, perform audits of contract facilities, and ensure compliance with ISO13485, ISO11137/11135, 21 CFR 820 and GMP.