2 часа назад
Senior Manufacturing Systems Engineer (Biotech)
136 900 - 181 900$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manufacturing Systems Engineer (Biotech): Supporting and optimizing manufacturing systems and OT infrastructure at a pharmaceutical facility with an accent on system reliability, GxP compliance, and operational continuity. Focus on maintaining validated systems, leading incident response and recovery activities, and improving manufacturing IT services across cross-functional teams.
Location: Hopewell, New Jersey, United States; occasional visits to other BeOne sites and vendor sites
Salary: $136,900–$181,900 annually
Company
develops medicines and operates pharmaceutical and biotechnology manufacturing activities focused on improving cancer treatment access.
What you will do
- Maintain and troubleshoot manufacturing systems to support uninterrupted operations.
- Support OT infrastructure, including backups, disaster recovery, security, and proactive maintenance.
- Lead incident management, system restores, service delivery, and customer support.
- Ensure manufacturing IT services remain audit-ready and compliant with GxP and FDA requirements.
- Collaborate with Quality, Validation, Business Process Owners, and other cross-functional teams.
- Drive continuous improvements to system performance, operational processes, and user experience.
Requirements
- Bachelor’s degree in information technology, computer science, engineering, or a related field.
- 7+ years of progressive IT experience supporting manufacturing systems.
- Experience with manufacturing systems and OT infrastructure, including DCS, bioreactors, filling machines, packaging lines, integrated skids, elogbooks, EBR, and MES.
- Knowledge of GxP regulations, GMP, and GAMP 5, including audits, walkthroughs, observations, and validated system lifecycle activities.
- Experience with URS, IQ, OQ, SOPs, change control, deviation management, and CAPA.
- Proficiency with Windows Server AD, AWS, MS-SQL, Smartsheet, Veeam, and Veeva.
Nice to have
- Pharmaceutical or biotechnology industry experience.
- Project management and Lean Six Sigma Green Belt training or experience.
- Experience supervising contractors and project resources.
Culture & Benefits
- Full-time position within the Global Technology Services organization.
- Collaborative environment focused on teamwork, continuous learning, initiative, and operational excellence.
- Medical, dental, vision, life insurance, FSA/HSA, 401(k), paid time off, and wellness benefits.
- Eligibility for annual bonus participation, discretionary equity awards, and an employee stock purchase plan.
- Equal opportunity employment with reasonable accommodation available during the application process.
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