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 GMP clinical manufacturing of advanced therapeutics and aims to transform the time and cost associated to produce medicines for our clients. This will be 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 will create & implement a seamless handover process from APC process development into GMP manufacturing, leveraging our novel platforms to deliver as a Medicine Accelerator. This is a unique opportunity for the successful candidate to become involved in ATMP and related pharmaceutical developments.
To create the best client experience, we will create & implement 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 are constructing a new state of the art biomanufacturing facility. Operations will employ 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.
Position Summary
This Facilities, Utilities, & Maintenance Engineer (FUME) role will report to the FUME Manager and will be responsible for the management of the maintenance (Mechanical, Electrical, Instrumentation, & Equipment) for Facilities and Utilities across the company (APC & VLE Therapeutics). Key responsibilities will include maintenance and reliability of the sites Facilities, Laboratories and Utilities This is a key role that will require excellent stakeholder management and influencing skills and will interact with all levels of the organisation ensuring competing priorities are managed objectively and in line with the overall business strategy.
Responsibilities of the Role
Coordinate and execute the day-to-day maintenance of facilities, utilities, and equipment across GMP and non-GMP areas.
Report all incidents, deviations, or abnormal conditions to the FUME Manager promptly.
Liaise with staff across labs, offices, and plant areas to ensure facility needs are met in a compliant and timely manner.
Support the FUME Manager with staff requests, external service providers, vendor management, and supplier coordination.
Manage contractor activities including administration, review of risk assessments and method statements (RAMS), and issuance/closure of Permits to Work.
Schedule, oversee, and document preventative maintenance (PM) activities with subcontractors.
Log and track all maintenance visits, interventions, and completed work orders in PEMAC/Asset Tiger.
Perform routine inspections of buildings, utilities, and plant equipment, escalating maintenance issues for timely resolution.
Conduct daily/weekly walkdowns of plant and critical utilities (e.g., HVAC, chilled water, boilers, gases) to identify risks and prevent unplanned downtime.
Support equipment reliability by raising work orders, tracking corrective actions, and ensuring spare parts availability.
Assist in drafting and reviewing quality documents such as Deviations, CAPAs, and Change Controls related to facilities/utilities.
Ensure all activities comply with GMP, safety, and regulatory requirements; support HPRA/EMA audit readiness.
Maintain a safe and healthy work environment in line with site EHS procedures and GMP standards.
Participate in vendor reviews, KPI tracking, and continuous improvement initiatives for maintenance operations.
Provide input into site shutdown planning, equipment calibrations, and system upgrades as required.
Undertake ad-hoc responsibilities as required in line with business needs
Experience & Qualifications
More than 3 years' experience in the maintenance of cGMP Pharmaceutical Operations, is essential.
More than 3 years' experience in the maintenance of GMP manufacturing is essential.
Aseptic operations experience is preferable.
Demonstrated experience in supporting the maintenance, repair and troubleshooting of complex equipment
Demonstrated ability to use problem solving tools within a team environment such as 5 Whys, DMAIC e.g. Method 1 is desirable.
Experience writing quality documents such as Deviations, CAPAs, and Change Controls.
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.
Education
Degree in a related engineering discipline or equivalent experience along with a Technical Qualification (C&G or equivalent)
How to apply
Suitable candidates should submit a CV and a Cover Letter by close of business 27th September 2025
APC/VLE is committed to the principle of equal opportunity for all employees. All employment decisions at APC/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.
Similar vacancies arising in the coming 6 months may be filled from this group of applicants.