Maintenance Technician
About VLE Therapeutics
Powered by transformation research in APC, VLE Therapeutics Ltd was formed to extend the value chain and deliver science and digital led manufacturing of Vaccines and Advanced Therapeutics. VLE Therapeutics will support the GMP manufacturing of clinical and commercial vaccines, next generation biologics & advanced therapeutics and aims to transform the time and cost associated to produce medicines for our clients. This is the first Irish-owned facility expressly designed to provide Ireland and Europe with a local supply chain for these critical medicines.
To create the best client experience, we have created & implemented a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver a Molecule-2-Market accelerator.
Stage 1 - At our current APC facility, we have constructed a new state of the art biomanufacturing facility. Operations are employing cutting edge technology including single use equipment & disposables and deploy digital solutions to support the best client experience.
Stage 2 - In parallel, we are planning the development of a bespoke 80,000ft2 greenfield GMP manufacturing facility, which will provide a world-class platform for the manufacture of a wide range of vaccines next generation biologics & advanced therapeutics for our clients globally.
Key to enabling our strategy is to create the best culture, the right values & behaviours and as a result, the establishment of a high performing team committed to creating a culture of excellence in everything we do.
Job Summary
We are seeking a skilled and trade-qualified Maintenance Technician (mechanical or electrical) to join our facilities, utilities & maintenance engineering team, supporting the operation and maintenance of our state-of-the-art pharmaceutical manufacturing and development facilities in Ireland. The successful candidate will be responsible for both preventative and corrective maintenance of specialized equipment, systems, and infrastructure, ensuring optimal performance and compliance with regulatory standards. This role requires strong vendor management, problem-solving skills, and the ability to work efficiently within a multidisciplinary team.
Key Responsibilities:
1. Preventive and Corrective Maintenance:
Oversee scheduled preventive maintenance on equipment, machinery, and systems within the R&D and GMP facilities, ensuring they operate within defined standards for each area. Respond to corrective maintenance requests promptly, diagnosing and troubleshooting mechanical and electrical faults, and restoring equipment to full operational status. Ensure compliance with GMP regulations and documentation standards during maintenance activities related to the GMP facility.
2. Equipment Repair and Troubleshooting:
Repair and maintain facility infrastructure including fume hoods, lab equipment, CO2 Incubators. Conduct root-cause analysis on recurring issues to drive effective CAPA and long-term solutions to minimize downtime.
3. Vendor Management:
Oversee external contractors and vendors performing maintenance or servicing of equipment, ensuring work is completed on time, within scope, and in compliance with GMP and safety standards. Obtain quotations, schedule services, and manage supplier relationships, ensuring cost-effective and timely delivery of required parts or services. Monitor contractor performance, ensuring all work is performed in line with the facility’s safety and quality requirements.
4. Compliance and Documentation:
Maintain accurate records of maintenance activities, equipment performance, and repairs using computerized maintenance management systems (CMMS). Ensure that all maintenance procedures are compliant with regulatory and safety standards. Support internal and external audits by providing necessary documentation and reports.
5. Safety and Training:
Follow all health, safety, and environmental procedures, contributing to a safe working environment. Participate in continuous improvement initiatives and training programs to stay updated on technological advancements and compliance requirements.
Key Experience & Qualifications:
1. Trade-qualified in either Mechanical or Electrical / E&I discipline.
2. Proven experience in a maintenance role within a GMP or Development environment, preferably within the pharmaceutical, biotech, or healthcare industries.
3. Strong technical knowledge of mechanical and electrical systems, including troubleshooting and diagnostics.
4. Experience with vendor management, including the coordination and oversight of contractors and service providers.
5. Ability to work effectively under pressure in a fast-paced environment, prioritizing tasks efficiently.
6. Excellent communication and interpersonal skills for working with internal teams and external vendors.
Preferred Skills:
1. Familiarity with Computerized Maintenance Management Systems (CMMS) and asset tracking tools.
2. Knowledge of GMP regulations and compliance pertinent to pharmaceutical, healthcare and biotechnology industries.
Work Environment:
Fast-paced R&D and GMP environment, requiring flexibility, responsiveness and a comprehension of where compliance and regulation is applicable. Work may require shifts, including some evenings, weekends, or on-call availability as needed.
How to apply:
Suitable applicants should submit a CV and Cover Letter by Friday November 22nd, 2024. VLE is committed to the principle of equal opportunity for all employees. All employment decisions at VLE are based on business needs, job requirements and individual qualifications, without regard to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and/or expression, marital status, or any other status protected by Irish law.
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