- As part of an ongoing start-up for sterile drug product manufacturing facility, we are now sourcing a Manufacturing Technical Lead. Reporting to the Manufacturing Manager, you will provide technical leadership support sterile manufacturing operations.
- Manufacturing representative on site technical transfer and scale up projects.
- Manufacturing representative on site launch projects for new market.
- Subject matter expert for manufacturing processes in compounding and sterile/aseptic processing.
- Mentor and drive the manufacturing group to be able to become experts on the manufacturing processes that they use.
- Oversees and authors process fit assessments and schedule adherence to each aspect of the tech transfers from manufacturing perspective.
- Provides direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits.
- Plays a Lead role within the manufacturing team to drive continuous improvement initiatives and projects.
- Supports processing via in-plant coverage and troubleshooting process deviations, as well as identifying opportunities for process improvements
- Provides required technical guidance for SOP’s required for manufacturing.
- Provides required technical guidance and approval for manufacturing batch records.
- Actively participates in an environment which fosters safety, quality and continuous improvement in cost and customer service.
- Interacts with process engineering and engineering teams to ensure effective investigation and remediation of technical performance issues with manufacturing equipment.
Education & Qualifications Required:
- Bachelor’s Degree in engineering, science or closely related discipline.
- Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises management as to the appropriate actions.
- Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.