Biotech Facility Validation Manager
2 weeks ago
This role involves working as part of a larger team to validate and maintain the biotech facility equipment, utilities, instrumentation, and computerized systems in accordance with relevant regulatory requirements.
- Design, develop, and execute qualification protocols and reports.
- Coordinate with vendors and contractors for qualification activities.
- Lead CSV projects, focusing on equipment and system validation.
- Regularly assess data integrity to ensure compliance.
- Maintain up-to-date records for equipment and building monitoring systems.
- Implement and enforce SOPs, cGMP, quality standards, and safety procedures.
- Support internal and regulatory agency audits and inspections.
- Maintain GMP compliant training programs.
A Bachelor's degree in a relevant scientific or engineering field is required; a Master's degree is preferred.
At least five years of experience in validation, engineering, or operations is necessary.
The estimated annual salary range for this position is $130,000-$160,000, taking into account industry standards and location factors.
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