Lead Specialist, Sterilization and Microbiology - Exton, PA

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

Lead Specialist, Sterilization and Microbiology

Exton, PA

The Lead Specialist, Sterilization and Microbiology will support the maintenance of all sterilization activities for Biomedical manufactured products, the execution of site contamination control policies and procedures, managing environmental monitoring program, 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 will work in partnership with Supplier Quality Assurance team to drive continual improvement in the sterilization processes and services of Biomedical Exton’s sterilization providers.

Key Responsibilities:

• Responsible for supporting sterilization activities performed on products manufactured at site, including dose audits and EO requalification assessments
• 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.
• Serve as support for supplier compliance to company sterilization sciences and biological safety systems and standards including authoring and reviewing validations and product adoptions into existing processes.
• 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/perform test method validations for lab related testing such as bioburden or endotoxin testing
• Support disposition and correction steps of NCR processes as necessary or required in the microbiology, sterilization, and product safety function
• Perform gap analyses of any applicable standards and ensure dsm-firmenich continued compliance and conformance to these standards
• Support 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 with experience within the medical device/pharmaceutical industry
• 3-5 years experience in QA/QC, preferably within the scope of microbiological control in Medical Device/Pharmaceutical Manufacturing
• Sterilization experience (gamma, Ebeam, EtO), required
• Environmental monitoring, nice to have
• Clean room experience, nice to have
• Quality standards ISO13485 & MDD
• Sterilization related standards: ISO 11137, ISO 11135
• FDA Regulations & Guidelines, 21CFR820, GMP
• Excellent knowledge of quality management systems
• Change management/processes
• Knowledge of systems: Microsoft Office, SAP, & Document Management Systems

The Lead Specialist, Sterilization and Microbiology operates in a quality environment which is highly regulated. Advanced understanding of cGMP, ISO, USP, AAMI etc. standards is required. The role will interact with external auditors and external/internal customers. Thorough understanding of multiple device sterilization methods and requirements essential. Good statistical knowledge as related to Quality Assurance.

The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant’s job-related skills, experience, relevant education, or training, and primary work location. Salary: $66,000.00 - $90,000.00.

In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.

About dsm-firmenich

At dsm‑firmenich, we don’t just meet expectations – we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions – every single day. Whether it’s fragrance that helps you focus, alternative meat that’s better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you’re making a difference, we’ll make sure you’re growing too. With learning that never stops, a culture thatlifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They’re essential to our future. Because realprogress only happens when we go beyond, together.

Inclusion, belonging and equal opportunity statement

At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work – and that’s exactly the kind of culture we’re building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has thechanceto grow, contribute, and feel they belong. We’re proud to be an equal opportunity employer, and we’re serious about making our hiring process as fair and inclusive aspossible. From inclusive language anddiverse interview panels to thoughtful sourcing, we’re committed to reflecting the world we serve. We welcome candidates fromall backgrounds — no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we’re here to help – just let us know what you need, and we’ll do everything we can to make it work.

Agency statement

We’re managing this search directly at dsm-firmenich. If you’re applying as an individual, we’d love to hear from you. We’re not accepting agency submissions or proposals involving fees or commissions for this role.