Job Opportunity

Job Opportunity

DS Vaccine Process Associate

DS Vaccine Process Associate

Ireland Posted 2024-12-18

WuXi Vaccines, a subsidiary of WuXi Biologics, focuses on human vaccine discovery, development and manufacture. An exciting new addition to the WuXi Biologics family, WuXi Vaccines will bring to the global vaccine industry the world-class integrated platforms and CDMO business model on which WuXi Biologics reputation is based. In development is an integrated vaccine manufacturing facility with 240 million US Dollar investment, including drug substance manufacturing (DS), drug product manufacturing (DP), Manufacture Science and Technology Labs (MS&T) as well as Quality Control labs (QC), dedicated to manufacturing our partner's vaccine products for the global market.

Job Summary:

The primary responsibility of the DS Vaccine Process Associate will be to support and deliver on process and equipment operation/CQV/process validation activities during manufacturing start up and operations

Responsibilities:

Perform all core production activities in DS facility
Manufacturing processes include DS Downstream Processing (DSP) and Upstream Processing (USP) and Buffer / Media preparation
Support the development, commissioning & qualification of a new vaccines drug substance manufacturing equipment and subsequent transition to commercial manufacturing
Assist in maintaining a safety orientated culture, cGMP compliant work environment at all times
Responsible for completion of manufacturing tasks according to SOPs and batch records (paper and electronic)
Perform initial troubleshooting of issues identified during routine operations
Assist with the investigation of manufacturing deviations through Quality System, engaging with all relevant personnel and functions as appropriate
Write, review, revise and approve of area SOPs, Logbooks, Training Competencies and Work Instructions
Training and mentoring of colleagues in SOPs, process execution and equipment operation
Seek opportunities for Continuous Improvement through the use of Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, etc.)
Where necessary assist in any in Facility and Equipment start up and Validation activities
Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations
Capable of working with individuals and with a team of up to 20 people
Provide technical leadership by acting as ‘Champion’ to drive improvements and excellence within specific aspects of the manufacturing operation within the shift team e.g. Environmental Monitoring, Lean, etc.
Provide manufacturing status update during shift handovers
Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training
Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested
Conduct all activities that are in accordance with Company policies & SOPs, WuXi values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.

Education & Experience:

Certificate, Diploma, Degree, Trade qualification or equivalent with 12 months plus experience in a regulated environment
A keen interest and desire to develop a career it the pharma industry
Experience working as part of a team
Experience with recording information in real time using electronic or manual systems
Experience in executing operations while following SOPs, Batch Records and Manufacturing Controls Systems desirable
Experience in biopharmaceutical industry is an advantage
Experience of working in Grade CNC, C and D environment is an advantage
Experience of working in Drug Substance USP or DSP is a significant advantage
Involvement working in a fast-paced green field project would be an advantage

This position will initially operate standard office hours Monday-Friday but will transition to a 12hr extended days shift pattern or 4 Cycle shift pattern.

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