6 дней назад
Specialist Manufacturing I (Biotech Manufacturing)
113 173 - 145 503$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Specialist Manufacturing I (Biotech Manufacturing): Leading and supporting manufacturing initiatives, process improvements, quality records, standard operating procedures, and production-floor execution with an accent on GMP operations, Lean manufacturing, Six Sigma, and data-driven performance analysis. Focus on validating manufacturing line layouts, managing deviations and CAPA, coordinating cross-functional teams, and mitigating operational risks.
Location: US - Rhode Island - West Greenwich; Flex Commuter / Hybrid
Salary: $113,173–$145,503 annual base salary in the U.S.
Company
is a biotechnology company researching, manufacturing, and delivering medicines across oncology, inflammation, general medicine, and rare disease.
What you will do
- Lead and support planning and execution of manufacturing initiatives with cross-functional teams on the production floor.
- Coordinate NPI and PRI preparation, implementation, sustainment, and lessons learned across manufacturing and partner functions.
- Analyze process-performance data and provide subject matter expertise for the assigned area.
- Own quality records, including change controls, CAPA, deviations, and supporting documentation.
- Develop standard operating procedures, training materials, and process improvements with Quality, Process Engineering, Regulatory, and Process Development.
- Support manufacturing organizations in prioritizing activities, maximizing plant performance and capacity, and mitigating operational risks.
Requirements
- Master’s degree or foreign equivalent in Regulatory Affairs and Quality Assurance, Bioengineering, Chemical Engineering, or a related field.
- Two years of experience in the offered role or a manufacturing-related occupation.
- Two years of experience implementing Lean manufacturing, Six Sigma, continuous improvement, and operational excellence tools such as 5S, Fishbone, Poka Yoke, and standard work.
- Experience with GMP production operations, data analysis, control charting, and manufacturing safety programs.
- Experience with Spotfire, MES/PAS-X, PI System, TrackWise, Veeva, and SAP.
- Project management experience, including cross-functional collaboration to validate manufacturing line layouts against equipment and process requirements.
Culture & Benefits
- Collaborative, innovative, science-based work environment focused on improving patient outcomes.
- Medical, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plans with company contributions.
- Eligibility for an annual bonus and stock-based long-term incentives.
- Paid time off, work-life balance programs, and career development opportunities.
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