Bioprocessing 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 will be the first Irish-owned facility expressly designed to provide Ireland and Europewith 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 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
A key member in supporting the execution of operational readiness in VLE therapeutics manufacturing facility. The manufacturing associate will become SME in a number of unit operations throughout the process and is responsible for executing batch operations as per standard operating procedures under limited supervision.
Principal Responsibilities
Demonstrate high performance behaviours, ability to work collaboratively within a cross functional team, ability to show independent initiative, to have a focus on continuous improvement and have a strong belief in supporting the right culture in the business.
Equipment maintenance SME within the Drug Product Aseptic Operations team.
Perform preventative and corrective maintenance of process equipment in Drug Substance Facility in accordance with cGMP and Good Engineering Practices (GEP).
Active member of Operations 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 with 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 Engineering & manufacturing team 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 Operations 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 Operations 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
Experience & Qualifications
More than 5 years’ experience in cGMP Pharmaceutical Operations is essential.
More than 5 years’ experience in Drug Substance Biologics manufacturing is essential.
Vaccine manufacturing experience is preferable.
Advanced Therapeutics (Cell & Gene Therapy) manufacturing experience is a positive.
Aseptic operations experience is preferable.
The role may operate on rotating shift position and may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend process operations.
Demonstrated experience in the maintenance, repair and troubleshooting of complex equipment including one or more of electrical, automation and mechanical issues is required.
Demonstrated ability to use problem solving tools within a team environment such as 5 Whys, DMAIC e.g. Method 1 is desirable.
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.
Must be able to read, write and converse in English.
Must have good working knowledge of MS Excel and Word
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
- Technical Engineering qualifications (C&G or equivalent) at a minimum. Degree in an engineering discipline or equivalent experience preferred.
How to apply: Suitable applicants should submit a CV and Cover Letter. Please note that the closing date for applications for this position is Monday 13th January 2025
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.
