Biotech Facility Validation Manager

2 weeks ago


Abingdon, Oxfordshire, United Kingdom Replimune, Inc. Full time
Job Description

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.
Key Responsibilities
  1. Implement and enforce SOPs, cGMP, quality standards, and safety procedures.
  2. Support internal and regulatory agency audits and inspections.
  3. Maintain GMP compliant training programs.
Requirements

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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