Vaccines Process Associate (VPA)

September 3, 2024

WuXi Biologics

Dundalk

Vaccine Process Associate (VPA), Drug Product

Wu Xi Vaccines, a subsidiary of Wu Xi Biologics, focuses on human vaccine discovery, development and manufacture. An exciting new addition to the Wu Xi Biologics family, Wu Xi Vaccines will bring to the global vaccine industry the world-class integrated platforms and CDMO business model on which Wu Xi 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.

Responsibilities:

Perform all core production activities in DP facility
Manufacturing processes include Formulation of Buffer, Stabilizer and Drug Product Filling, Capping and Inspection
Support the development, commissioning & qualification of a new vaccines drug product manufacturing equipment and subsequent transition to commercial manufacturing.
Assist in maintaining a safety orientated Culture, c GMP compliant work environment always
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, Batch Records, Logbooks, Training Competencies and Work Instructions
Training and mentoring of colleagues in SOPs, process execution and equipment operation.
Seek opportunities for Continuous Improvement using 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 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, Wu Xi values, & global regulatory guidelines (including c GMP/c GLP/c GCP), environmental guidelines, as appropriate, etc.
Due to the start-up nature of the project, there will be an expectation for flexibility and an ability to take on varied tasks at short notice not covered extensively within this job description.
The role is a shift based position.

Education & Experience:

A keen interest and desire to develop a career in 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.
Involvement working in a fast-paced green field project would be an advantage.
Certificate, Diploma, Degree, Trade qualification or equivalent demonstrated experience of 12 months or more experience in a regulated environment.
Excellent interpersonal skills, positive influence, team orientation, attention to detail, documentation skills, problem identification and problem-solving skills
An ability to work independently, and as a member of a self - managed shift team in a dynamic, fast-paced environment that requires flexibility and initiative.