Lead Specialist, Sterilization and Microbiology - Exton, PA

Lead Specialist, Sterilization and Microbiology\n\nExton, PA\n\nThe 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\u2019s sterilization providers. \n\nKey Responsibilities:\n\n * Responsible for supporting sterilization activities performed on products manufactured at site, including dose audits and EO requalification assessments\n * Manage and maintain corporate internal and sub-contracted testing programs for assurance of patient safety including sterile product release and contamination control. \n * 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. \n * 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. \n * 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. \n * Oversee the Environmental Monitoring Program and Controlled Environment qualification activities, and implement and maintain adherence to Controlled Environment policies and procedures \n * Support/perform test method validations for lab related testing such as bioburden or endotoxin testing\n * Support disposition and correction steps of NCR processes as necessary or required in the microbiology, sterilization, and product safety function\n * Perform gap analyses of any applicable standards and ensure dsm-firmenich continued compliance and conformance to these standards\n * Support viral inactivation studies risk assessments as related to viral safety \n * Support execution of annual zoonosis reports and literature reviews for animal derived product \n\n\n\nWe Bring:\n\n * A competitive compensation package, with comprehensive health and welfare benefits\n * A place to grow and develop\n * A company that is purpose-led and performance-driven in a corporate culture that values people and planet\n * The opportunity to work on growing brands and build on a strong foundation\n * The chance to make improvements and make an impact on the business\n\n\n\nYou Bring:\n\n * Bachelor\u2019s degree in Biological science with experience within the medical device/pharmaceutical industry\n * 3-5 years experience in QA/QC, preferably within the scope of microbiological control in Medical Device/Pharmaceutical Manufacturing \n * Sterilization experience (gamma, Ebeam, EtO), required\n * Environmental monitoring, nice to have\n * Clean room experience, nice to have\n * Quality standards ISO13485 \u0026 MDD \n * Sterilization related standards: ISO 11137, ISO 11135\n * FDA Regulations \u0026 Guidelines, 21CFR820, GMP \n * Excellent knowledge of quality management systems \n * Change management/processes \n * Knowledge of systems: Microsoft Office, SAP, \u0026 Document Management Systems \n\n\n\nThe 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. \n\nThe 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\u2019s job-related skills, experience, relevant education, or training, and primary work location. Salary: $66,000.00 - $90,000.00.\n\nIn 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.\n\nAbout dsm-firmenich\n\nAt dsm-firmenich, we don\u2019t just meet expectations \u2013 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 \u2013 every single day. Whether it\u2019s fragrance that helps you focus, alternative meat that\u2019s 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\u2019re making a difference, we\u2019ll make sure you\u2019re 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\u2019re essential to our future. Because realprogress only happens when we go beyond, together.\n\nInclusion, belonging and equal opportunity statement\n\nAt 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 \u2013 and that\u2019s exactly the kind of culture we\u2019re building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has thechanceto grow, contribute, and feel they belong. We\u2019re proud to be an equal opportunity employer, and we\u2019re serious about making our hiring process as fair and inclusive aspossible. From inclusive language anddiverse interview panels to thoughtful sourcing, we\u2019re committed to reflecting the world we serve. We welcome candidates fromall backgrounds \u2014 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\u2019re here to help \u2013 just let us know what you need, and we\u2019ll do everything we can to make it work.\n\nAgency statement\n\nWe\u2019re managing this search directly at dsm-firmenich. If you\u2019re applying as an individual, we\u2019d love to hear from you. We\u2019re not accepting agency submissions or proposals involving fees or commissions for this role.\n