Bioprocessing Maintenance Technician - VLE Therapeutics
SPEEDECK
Dublin
EUR 40,000 - 60,000
Be among the first applicants.
7 days ago
Description
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.
This will be the first Irish-owned facility expressly designed to provide Ireland and Europe with a local supply chain for these critical medicines.
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.
* 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.
* 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.
* 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.
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