10 дней назад
Staff Engineer (MSAT)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Staff Engineer (MSAT): Managing a CMO portfolio covering approximately 85% of site manufacturing volume, translating customer requirements into executable plans, and coordinating pharmaceutical lifecycle management with an accent on process changes, validation, packaging, regulatory compliance, and uninterrupted product supply. Focus on leading cross-functional GMP projects, managing customer commitments and risks, and aligning MSAT, Quality, Operations, Regulatory Affairs, Procurement, and other functions.
Location: Xi'an, Shaanxi, China
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions designed to improve treatment and patient outcomes.
What you will do
- Own a CMO portfolio representing approximately 85% of the site's manufacturing volume.
- Act as the primary customer-facing contact for CMO-related activities and translate customer needs into site execution plans.
- Lead lifecycle management initiatives covering process changes, process and cleaning validation, packaging and artwork updates, and regulatory-driven changes.
- Build project plans, timelines, milestones, and deliverables while coordinating MSAT, Quality, Operations, GETs, Procurement, and Regulatory Affairs.
- Track project risks, develop mitigation plans, resolve issues, and ensure customer commitments support site priorities and uninterrupted product supply.
Requirements
- Bachelor's degree or above in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or a related discipline.
- At least 8 years of experience in pharmaceutical manufacturing, MSAT, supply chain, project management, technical operations, or a related function.
- Experience leading cross-functional projects in a GMP-regulated environment and knowledge of pharmaceutical product lifecycle management.
- Strong understanding of pharmaceutical manufacturing, process validation, cleaning validation, packaging operations, commercialization, quality systems, and regulatory requirements.
- Strong project management, stakeholder management, communication, influencing, problem-solving, and risk management skills.
- Fluent English, both written and verbal, is required.
Nice to have
- Experience working with Contract Manufacturing Organizations or external customers.
- Knowledge of lean manufacturing, lean supply chain management, manufacturing engineering, robotic automation, SOPs, supply planning, or team management.
Culture & Benefits
- Inclusive work environment focused on individual dignity, diversity, and merit.
- Work within a healthcare innovation organization spanning Innovative Medicine and MedTech.
- Collaborate across multiple technical, operational, quality, regulatory, and commercial functions.
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