4 дня назад
GMP Maintenance Technician II (DPI)/ Senior GMP Maintenance Technician (DPI)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
GMP Maintenance Technician II (DPI)/ Senior GMP Maintenance Technician (DPI) (pharmaceutical manufacturing): Maintaining and repairing manufacturing, filling, assembly, and packing/kitting equipment for Tyvaso DPI production with an accent on cGMP compliance, automation, and equipment reliability. Focus on troubleshooting mechanical, electrical, pneumatic, and hydraulic systems, coordinating vendor maintenance, and supporting validations, quality events, and process improvements.
Location: 100% on-site at the Durham, NC office
Company
is a public benefit biotechnology and pharmaceutical company developing therapies for rare diseases and technologies for manufactured transplantable organs.
What you will do
- Perform planned and unplanned maintenance and repairs on manufacturing, filling, assembly, and packing/kitting equipment supporting Tyvaso DPI production.
- Troubleshoot mechanical, electrical, pneumatic, hydraulic, and automated equipment issues, including non-routine problems.
- Perform preventive maintenance and maintain accurate records in BMRAM and the computerized maintenance management system.
- Coordinate with mechanics, stakeholders, and external vendors during equipment maintenance and site visits.
- Support quality events, deviations, change controls, CAPAs, audits, validations, and special projects.
- Help improve equipment setup, performance, reliability, and spare-parts inventory management.
Requirements
- High school diploma or GED.
- At least 4 years of industrial, pharmaceutical, biotechnology, or manufacturing maintenance experience for Technician II; at least 6 years for the Senior Technician role.
- Experience troubleshooting and repairing pneumatic, electronic, and hydraulic control systems.
- Experience with automation systems and platforms, including the ability to operate and troubleshoot complex systems for the senior role.
- Working knowledge of digital voltmeters, temperature probes, and pneumatic calibrators.
- Strong organization, problem-solving, communication, multitasking, and cross-functional collaboration skills, with the ability to guide less experienced technicians.
Nice to have
- Associate degree in life science, mechanical, or technical vocational studies.
- Experience with regulated databases such as BMRAM or Cal Man.
- Four or more years of pharmaceutical or medical device industry experience.
Culture & Benefits
- Work in a mission-driven public benefit corporation focused on unmet medical needs.
- Collaborate with internal teams, external vendors, and manufacturing stakeholders.
- Support innovative pharmaceutical therapies and technologies intended to expand access to transplantable organs.
- Some travel to other or vendor sites may be required.
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