Essential Duties and Responsibilities:
Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures. Able to coach and mentor others to do the same
Identifies, communicates, addresses, and improves simple cGMP compliance and regulatory gaps and issues; and participates/implements continuous improvement ideas
Participates, provides information in the development of and authors basic technical documents such as non-conforming events and deviations
Experience in using single use bioreactors (Wave, Sartorious, Xcellerex etc.)
Leverages knowledge and application of the theories and principals utilized to solve operational, as well as routine tasks in the operation of microbial or cell culture processes (cell passaging, bioreactor production, harvesting operations)
Experience with automated or semi-automated fermenters, bioreactors, holding tanks, aseptic operations, seed scale-up, harvest equipment, and cleaning and sterilization procedures for biopharmaceutical products
Operates, maintains, and troubleshoots equipment
Participates on and performs technical transfer, validation and other facility start up activities
Uses all support systems (e.g. LIMS) with demonstrated proficiency and able to act as an subject matter expert (SME) on a system
Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices
Follows, executes, authors, and improves the efficiency and execution of Standard Operating Procedures (SOPs) and Batch Records (BRs)
Trains others on SOPs, equipment, and all unit operations
Identifies, participates, and suggests solutions to technical problems
Participates, supports, and assists as an SME during regulatory inspections and client audits
Performs well under direct supervision and works independently on basic tasks and processes
May be required to work Holidays/ weekends, overtime & work outside normal business hours
Contributes to the overall operations and to the achievement of departmental goals
Other duties as assigned
Qualifications:
HS Diploma required with minimum 4-5 years of relevant manufacturing experience
BS/BA in Science related field with 2-3 years of relevant experience preferred.
Experience with single use bioreactor, cell culture and cGMP manufacturing
Experience with product recovery by centrifugation, clarification, depth filtration etc.
Position Manufacturing Technician III
Department MFG 11 or MFG 18
Business Unit Biologics
Line Manager MFG Supervisor or Higher
Understands most operations and functions of equipment and is able to perform minor troubleshooting
Possesses basic technical knowledge and background in the biotechnology industry
Possesses basic and fundamental facility start-up experience
Possess basic computer skills and able to efficiently use basic Microsoft applications
Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
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
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