Validation Engineer (APS) (Boston)JMD Technologies Inc. • Boston, MA, United States
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Validation Engineer (APS) (Boston)
JMD Technologies Inc. • Boston, MA, United States
Hace 16 horas
Tipo de contrato
- A tiempo completo
Descripción del trabajoExecute aseptic process simulations (APS) and support process validation activities, including documentation, execution, and result review. Develop and author validation protocols such as URS, IQ, OQ, and PQ in alignment with GDP and GMP standards. Perform equipment and analytical instrument qualification following regulatory and internal guidelines. Conduct automation and software compliance assessments to ensure adherence to 21 CFR Part 11 requirements. Coordinate cross-functional activities with engineering, quality, IT, vendors, and operations to complete CQV (Commissioning, Qualification & Validation) tasks. Support validation of automated manufacturing systems and sterile process controls. Maintain accurate, audit-ready validation documentation in compliance with quality system requirements. Participate in off-shift or weekend APS execution while maintaining a standard 40-hour workweek. Ensure all work aligns with applicable SOPs, regulations, and Good Documentation Practices (GDP) .
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Validation Engineer • Boston, MA, United States
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