4 дня назад
Equipment Process Engineer (Fill-Finish)
55 960 - 75 711€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Equipment Process Engineer (Fill-Finish) (GMP/aseptic manufacturing): Owning and improving capping equipment and associated systems for sterile drug-product manufacturing with an accent on equipment reliability, lifecycle management, compliance, and technical performance. Focus on troubleshooting complex equipment failures, implementing CAPAs and upgrades, supporting validation and qualification activities, and managing supplier-led projects.
Location: Dun Laoghaire, Ireland; onsite engineering work in a GMP-regulated sterile manufacturing facility. Travel may be required for vendor activities, factory acceptance testing, and project execution.
Salary: €55,960.60–€75,711.40 per year
Company
operates a biotechnology manufacturing site in Dun Laoghaire focused on sterile drug-product production.
What you will do
- Own assigned capping equipment and associated systems across reliability, availability, performance, lifecycle planning, and continuous improvement.
- Monitor equipment performance, uptime, output, reject rates, cap and stopper placement, container handling, and recurring faults.
- Lead or support troubleshooting, root-cause analysis, deviation investigations, non-conformance resolution, and CAPA implementation.
- Develop engineering specifications, risk assessments, user requirements, functional designs, GMP procedures, maintenance strategies, and lifecycle documentation.
- Support equipment upgrades, new equipment introductions, FAT, SAT, commissioning, engineering runs, qualification, and validation activities.
- Collaborate with Manufacturing, Maintenance, Quality, Process Development, Automation, Validation, and external equipment suppliers.
Requirements
- Bachelor’s degree in Engineering, preferably Mechanical, Electrical, Mechatronic, Automation, or a related discipline.
- More than 2 years of relevant engineering experience in pharmaceutical, biotechnology, medical-device, or another highly regulated manufacturing environment.
- Experience with equipment ownership, reliability engineering, lifecycle management, technical troubleshooting, and continuous improvement.
- Strong mechanical and electromechanical engineering capability in a manufacturing environment.
- Experience with change control, deviations and non-conformances, CAPAs, risk assessments, validation, and qualification.
- Strong communication and collaboration skills, including work with cross-functional teams and external suppliers.
Nice to have
- More than 4 years of experience in sterile manufacturing, fill-finish, aseptic processing, pharmaceutical, biotechnology, or medical-device manufacturing.
- Direct experience with capping equipment, cap feeding and orientation, rotary or inline cappers, crimping, container handling, reject systems, and associated controls.
- Experience with vial, syringe, or cartridge filling, contamination control, and container-closure critical quality attributes.
- Experience with PLC-controlled systems, servo systems, robotics, vision systems, SCADA, or manufacturing data systems.
- Experience with vendor management, spare-parts strategy, statistical analysis, structured problem solving, and continuous-improvement methodologies.
Culture & Benefits
- Work in a collaborative, team-based engineering environment supporting manufacturing operations.
- Contribute to site expansion, new product introductions, technology transfers, capacity improvements, and capital investment projects.
- Support a safe, compliant, and quality-focused GMP workplace.
- Manage competing priorities in a fast-paced production environment while working with internal teams and equipment suppliers.
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