Job Opportunity

Job Opportunity

VMT

VMT

Ireland Posted 2024-04-08

Vaccine Maintenance Technician (VMT), Drug Product

RESPONSIBILITIES:

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

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

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