Vaccine Maintenance Technician (VMT)

at  WuXi Biologics

REQUIREMENTS:

• Certificate, Diploma, Degree, Trade qualification in Engineering related discipline
• Demonstrated experience in the maintenance, repair and troubleshooting of complex equipment including one or more of electrical, automation and mechanical issues is required.
• Experience working as part of a team is required
• Experience with cGMP and sterile area requirements for pharmaceutical clean rooms is advantageous
• Engineering experience with the following equipment is highly advantageous: vial filling systems, isolator technology, automated visual inspection technology, lyophilisation equipment, autoclave, biosafety cabinets and formulation.
• Demonstrated ability to use problem solving tools within a team environment such as 5 Whys, DMAIC e.g. Method 1 is desirable.
• Experience in supporting execution of SAT, IQ, OQ protocols is advantageous
• Experience in use of Engineering Work Management System e.g. Maximo

OTHER SKILLS & ABILITIES:

• 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
• Good interpersonal skills, and an adaptable and flexible approach to the role

OTHER INFORMATION:

• The role will be shift based
• 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

• Equipment maintenance SME within the Drug Product Aseptic Manufacturing team
• Perform preventative and corrective maintenance of process equipment in Drug Product Facility in accordance with cGMP and Good Engineering Practices (GEP)
• Active member of manufacturing team who will monitor line performance during batch processing and respond to equipment issues to minimize equipment downtime
• Troubleshoot equipment issues e.g. mechanical, electrical, automation, instrumentation issues within manufacturing facility
• Ensure that all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards
• Ensure that maintenance activities are completed in compliance Site Engineering policies and procedures
• Ensure that all work undertaken is reflected accurately in Work Order documentation and/or up to date Engineering / project information files
• Liaise with Maintenance Engineer & Manufacturing Planner to plan and execute planned preventative maintenance including review of drawings, OEM manuals and identification of required spare parts
• Liaise with and support the area Senior Engineer to escalate significant equipment issues, prioritise corrective maintenance between batches and to plan identified CI activities
• Support the development, commissioning & qualification e.g. Site Acceptance Testing of a new vaccines drug product manufacturing equipment and subsequent transition to commercial manufacturing
• Participate and support the following processes: Total Productive Maintenance (TPM), Continuous Improvement (CI), 5S, defect walk downs, 5S and quality investigations relating to equipment
• Own individual CI projects as identified through equipment data analysis via TPM & supported by Shift Lead
• Review and approve work executed by external contractors such as OEM suppliers & service providers
• Review/prepare maintenance procedures and Engineering Work Instructions (EWIs), and other relevant documentation, where required
• Provide training to colleagues as per site training procedures
• Review equipment spares holding levels and make changes post review
• Any other maintenance related activities as directed by the Shift Lead or Manufacturing Lead
• 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
• Perform role of Shift Lead Designee as required