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Process Engineer I

Company: ThermoFisher
Location: Somerville
Posted on: May 3, 2021

Job Description:

Job Title: Process Engineer I, Manufacturing Sciences & Technology - Drug ProductRequisition ID:When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.Location/Division Specific InformationUS - Massachusetts - Cambridge Manufacturing Science and Technology - Drug Product How will you make an impact?The primary responsibility is to support the technology transfer teams for the late stage, PPQ and commercial manufacturing of viral vectors. This position requires close interaction with the MS&T colleagues, Manufacturing, Process Development, and other departments. This role will focus on aspects of ensuring a robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer vector products.MST PE I will work closely with the MST teams to support client projects and with ThermoFisher's Florida site, PD, Quality, EHS, and Manufacturing to ensure compliance and technology transfer. Additionally, based on project assignment the role executes process characterization projects for ThermoFisher.What will you do? Supports cross functional technology transfer teams for cGXP DP manufacturing of viral vectors. Collaborate with another site or clients to ensure success of scale up/ process transfer. Ensure effective information flow, risk assessment, timeline execution, issue resolution and documentation for cross-functional teams.Execute MST process establishment runs, ensuring documentation is followed and completed real time.Work with external partners to support development, qualification, supply, and cGMP manufacture / packaging / labeling.Author or provide technical review of batch records for development/tech transfer and related cGMP documentation (e.g., raw material specifications, equipment specifications, validation, supportive development protocols / reports, applicable sections of CMC regulatory filings, etc.) and associated PDPRs.Author or assist in preparing PPQ protocols and reports. Assist in providing "man in plant' oversight to development and qualification related activities (eg. oversee execution of development, GMP and PPQ related activities).Collaborate with PS/PD/QC/QA to develop testing strategy for raw materials, start materials, intermediates, DS and DP.Develop sampling plans with clients and incorporate them into cGMP batch documentation.Maintain database containing pedigree of all GXP manufacturing and development activities (i.e., raw material lot #'s, assay, yield, deviations, and other critical attributes).Maintain critical quality attribute, in-process and release data tracking and trending analysis as well as in-process equipment parameter tracking and trending analyses.Support engineering teams on equipment selection, qualification, and start up vestigate root causes of major deviations for cGMP manufacturing and implement CAPA for major deviations.Maintain an accurate schedule/project plan of assigned MST lab work and deliverables.Support the MST laboratory to operate efficiently. This may include maintenance of inventory; experiment and equipment use scheduling; and maintenance of equipment.Identifying opportunities to improve systems and practices.Work with counterparts in ThermoFisher's Alachua Process Development and Cambridge Process Sciences, Manufacturing, Quality, Project Management teams etc. to facilitate technology transfer and project success.How will you get here?EducationBachelor degree in Biochemical, Chemical Engineering, pharmaceutical science or a related scientific discipline such as Chemistry or Biology.B.S. with less than 2 years' relevant experienceKnowledge, Skills, AbilitiesStrong interpersonal and communications skills; written and oral.Ability to function in a fast-paced dynamic team environment and balance prioritize multiple projectsLaboratory experience preferred.Knowledge of cell and gene therapy vector production highly desirable.Ability to be hands-onAbility to function in a rapidly changing environment & handle multiple priorities.Work Hours:Monday through Friday, 8:00 AM to 5:00 PM. Requires overtime to work evenings, weekends or holidays, as required to meet project timelines.Ability to lift up to 25 lbs.Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.JobSummaryJob number: 156360BRDate posted : 2021-04-13Profession: OperationsEmployment type: Full-TimeSDL2017

Keywords: ThermoFisher, Somerville , Process Engineer I, Other , Somerville, Massachusetts

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