Expert Equipment Validator
15 hours ago
We are seeking a highly skilled Equipment Validation Specialist to support a strategic decommissioning and qualification project in a GMP-regulated laboratory.
- Support the decommissioning of analytical instruments, ensuring compliance with internal procedures and regulatory standards.
- Manage the qualification workflow of laboratory equipment, including 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+) and current GMP regulations.
- 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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Expert Equipment Validator
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