Validating Laboratory Equipment for Regulatory Compliance

5 days ago

Singapore beBeeValidation Full time $90,000 - $120,000

Job Title: Equipment Validation Specialist

We are seeking a highly skilled Equipment Validation Specialist to support our strategic decommissioning and qualification project in a regulated laboratory environment.

Key Responsibilities:

  • Validate analytical instruments in a GMP-regulated laboratory, ensuring compliance with internal procedures and regulatory standards.
  • Manage the qualification workflow of laboratory equipment as needed, with hands-on involvement in protocols and reporting.
  • Draft and review decommissioning protocols and related documentation, aligned with GMP requirements and client-specific templates.
  • Collaborate with vendors, QA, and client stakeholders to ensure smooth execution of decommissioning and qualification activities.
  • Ensure all documentation and reports adhere to Data Integrity principles (ALCOA+), GAMP5 guidelines, and current GMP regulations.
  • Provide technical support and oversight during execution of decommissioning tasks, including removal, data migration/archiving, and closure activities.

About You:

  • 5-7 years of experience in laboratory equipment validation/CQV projects in GMP-regulated environments.
  • A solid understanding of equipment lifecycle management, with specific experience in decommissioning activities.
  • A background in usage, calibration, maintenance, and qualification/validation of analytical equipment and instrumentation used in biopharmaceutical QA, QC, R&D, or micro laboratory environments is required.
  • Fluent in English (written and spoken); Mandarin Chinese is a nice-to-have.
  • Strong communication and stakeholder management skills.
  • Detail-oriented, organized, and capable of managing multiple tasks under tight timelines.
  • A quality-driven mindset with strong ownership and accountability.

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