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Bioprocessing Maintenance Technician - VLE Therapeutics
Client:
APC Ltd
Location:
Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
481ae12ea01b
Job Views:
6
Posted:
06.03.2025
Expiry Date:
20.04.2025
Job Description:
Bioprocessing Maintenance Technician at VLE Therapeutics, 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, and advanced therapeutics.
Position Summary: A key member in supporting the execution of operational readiness in the VLE therapeutics manufacturing facility. The manufacturing associate will become a Subject Matter Expert (SME) in several unit operations and is responsible for executing batch operations as per standard operating procedures under limited supervision.
Principal Responsibilities:
1. Demonstrate high performance behaviors, work collaboratively within a cross-functional team, show independent initiative, and focus on continuous improvement.
2. Act as Equipment Maintenance SME within the Drug Product Aseptic Operations team.
3. Perform preventative and corrective maintenance of process equipment in accordance with cGMP and Good Engineering Practices (GEP).
4. Monitor line performance during batch processing and respond to equipment issues to minimize downtime.
5. Troubleshoot mechanical, electrical, automation, and instrumentation issues within the manufacturing facility.
6. Ensure compliance with industry standards for all work carried out and equipment installed.
7. Liaise with Engineering & manufacturing teams for planned preventative maintenance and escalate significant equipment issues.
8. Support the development, commissioning, and qualification of new vaccines drug product manufacturing equipment.
9. Participate in processes such as Total Productive Maintenance (TPM), Continuous Improvement (CI), and quality investigations.
10. Own individual CI projects as identified through equipment data analysis.
11. Review and approve work executed by external contractors and prepare maintenance procedures as required.
12. Provide training to colleagues per site training procedures.
13. Review equipment spares holding levels and make changes post-review.
14. Support the Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs).
15. Perform the role of Shift Lead Designee as required.
Experience & Qualifications:
1. More than 5 years’ experience in cGMP Pharmaceutical Operations.
2. More than 5 years’ experience in Drug Substance Biologics manufacturing.
3. Vaccine manufacturing experience is preferable.
4. Aseptic operations experience is preferable.
5. Demonstrated experience in maintenance, repair, and troubleshooting of complex equipment.
6. Ability to use problem-solving tools within a team environment.
7. Must be able to read, write, and converse in English.
8. Good working knowledge of MS Excel and Word.
9. Excellent interpersonal skills and attention to detail.
10. Ability to work independently and as part of a self-managed shift team.
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. The closing date for applications is Monday 13th January 2025.
VLE is committed to the principle of equal opportunity for all employees.
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