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Validation Engineer (APS) (Boston)
Validation Engineer (APS) (Boston)JMD Technologies Inc. • Boston, MA, United States
Validation Engineer (APS) (Boston)

Validation Engineer (APS) (Boston)

JMD Technologies Inc. • Boston, MA, United States
1 day ago
Job type
  • Full-time
Job description
  • Execute 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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