The Quality Technician II, Aseptic Control should autonomously perform tasks related to environmental monitoring to support the regulatory requirements of a sterile manufacturing site. This position requires operating equipment in various classified / non classified areas up to a Class 100 aseptic environment and in a laboratory setting. Position Responsibilities Prepare

Participates in the hands on manufacture of cell therapy products, using state of the art cell manufacturing technologies (i.e., CliniMACS Prodigy, Xuri Bioreactor, Finia Fill and Finish System, etc.), media preparation, cell culture maintenance, sampling and cell counting (i.e., NC200 and MultiSizer). Follows and executes batchrecords and standard operation procedures. P

Participates in the hands on manufacture of cell therapy products, using state of the art cell manufacturing technologies (i.e., CliniMACS Prodigy, Xuri Bioreactor, Finia Fill and Finish System, etc.), media preparation, cell culture maintenance, sampling and cell counting (i.e., NC200 and MultiSizer). Follows and executes batchrecords and standard operation procedures. P

Participates in the hands on manufacture of cell therapy products, using state of the art cell manufacturing technologies (i.e., CliniMACS Prodigy, Xuri Bioreactor, Finia Fill and Finish System, etc.), media preparation, cell culture maintenance, sampling and cell counting (i.e., NC200 and MultiSizer). Follows and executes batchrecords and standard operation procedures. P

Provide primary site technical support for the entire Tech Transfer process from initial evaluation to PPQ, including change control ownership, in compliance with site procedures. Define and own technical requirements for new equipment design specifications (URS) Develop and own site Control Strategy Documents for processes transferred Work with Project Managers to ensure

Role/Site Specific Requirements This role is primarily non sedentary. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects. Visual acuity such as working with data & figures, viewing computer terminals, extensive reading, operating machinery, general observations of facilities, etc. All employe

This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management

Member of the Engineering Dept and perform the functions of a Responsible System Engineer (RSE) for assigned systems. Lead, plan and execute the design, installation, qualification, operation, maintenance, and continuous improvement of mechanical systems as applied to BioPharma manufacturing facility (e.g. HVAC systems, Boilers, Heat exchangers, Compressors, Processes ves

Author, Review and approve documentation needed for qualification of equipment and processes. Serve as an SME to the entire Validation Process Commissioning, IOQ, PQ, PPQ, CPV Be a Validation Leader in the functional area assigned, Aseptic Activities, Packaging or Inspection Prepare documentation of activities, actions, and/or results. Monitor records to ensure compliance

Operate, monitor, troubleshoot, and perform maintenance tasks on various packaging equipment including picker, sorter, labeller, packer, checkweigher, printer, inspection equipment, palletizer, stretch wrapper and conveyors. Work collaboratively with technical resources to resolve equipment issues as needed. Act as a first line technical resource for the team. Provide tec

Performs tasks in support of the pharmaceutical manufacturing processes in Manufacturing. Specific requirements include authoring and revising of documents, authoring training materials, and The position provides oversight, execution, and approval for transactions in QAD as well as ensuring that OEE performance data is collected as specified for each operating area. Techn

This position is responsible for all QA activities that directly support the execution of the process both within the Pack Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier m

May provide leadership, direction, and control for all activities on small projects or portions of large projects within the areas of design, architecture, and engineering Coordinates the work of skilled staff and consultants with particular emphasis on meeting current schedules, budgets, business plans, and long range strategies of the organization Executes or assists in

Resilience is ushering in an era of "Biomanufacturing as a Service" that we expect will displace in house manufacturing as well as traditional contract manufacturing and development organizations (CDMOs). We see this as a paradigm shift in biomanufacturing akin to the IT industry's adoption of Infrastructure as a Service (IaaS) and Platform as a Service (PaaS) that render

A career at Resilience is more than just a job it's an opportunity to change the future. Resilience is a technology focused biomanufacturing company that's changing the way medicine is made . We're building a sustainable network of high tech, end to end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For