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Manufacturing Support Technician II/III

Company: WuXi Biologics
Location: Avenel
Posted on: November 22, 2021

Job Description:

Company Overview:WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. Job SummaryThis is a full time position, reporting to the Supervisor, Manufacturing Support. The Manufacturing Support Technician III will be a key member of the Manufacturing Support team and will work independently and in a team to contribute to the qualification, operation and overall success of the clinical manufacturing facility. This includes but is not limited to material weigh/dispense and medium and buffer preparation activities. Essential Job Functions-- Complete assigned tasks associated with biologics clinical manufacturing including material weigh/dispense and medium and buffer preparation activities.-- Analyze in process samples using osmometer, pH/conductivity meters, scales, etc.-- Train new employees on daily operations.-- Maintain the material dispensing, medium preparation and buffer preparation rooms in an inspection-ready state.-- Assist in developing, executing and reviewing SOPs and batch documentation as per cGMP and company guidelines.-- Assist in the completion of change control documentation and deviation investigation.-- Assist in troubleshooting equipment, as needed.-- May be required to work Shifts, Holidays and weekends-- Other duties as assigned Requirements-- Minimum 3 years' cGMP operations experience with 2+ years direct experience in medium and/or buffer preparation.-- Strong understanding of cGMPs as applicable to manufacturing of biologics.-- Strong communication and presentation skills.-- Excellent organization skills with ability to manage own work.-- Strong technical knowledge with demonstration of robust problem solving and continuous improvement.-- Must be able to work with a variety of teams, made up of both technical and non-technical personnel. Desirable-- Hands-on experience authoring and revision SOPs, Batch Records, etc.-- Experience with single-use manufacturing systems and design.-- Experience completing change control documentation and deviation investigations.-- An ability to work through peers and across organizational boundaries and influence at all levels in the business.-- Ability to efficiently use current computer packages in particular Excel, PowerPoint, MS Project and Word. Physical Requirements-- Must be able to work in an office environment with minimal noise conditions.-- Must be able to work in Lab setting with Biohazards / Various Chemicals-- Must be able to wear appropriate PPE-- Must be able to work in environment with variable noise levels-- Ability to Stand / Sit / Walk for long periods of time-- Ability to Lift / Push / Pull 50 lbs routinely-- Ability to crouch, bend, twist, and reach-- Clarity of vision and have the ability to identify and distinguish colors-- Must be able to perform activities with repetitive motions-- Ability to climb Ladders / Stairs / Scaffolding-- Ability to work in variable temperatures from high to freezing The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Keywords: WuXi Biologics, Elizabeth , Manufacturing Support Technician II/III, Professions , Avenel, New Jersey

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