GMP Clean Room Validation Consultant

Job Title : GMP Clean Room Validation Consultant

Location : Los Angeles, CA (Onsite)

Experience : 5 10 years

Duration : 12+ monthsContract

Job Overview :

We are seeking an experienced GMP Clean Room Validation Consultant to lead and execute GMP clean room re-qualification activities in alignment with Annex 1 requirements. This role involves coordinating clean room testing with manufacturing teams, executing and authoring validation protocols, and ensuring compliance within a paper-based validation system. The ideal candidate will have hands-on experience in pharmaceutical GMP environments and a strong understanding of clean room qualification processes.

Key Responsibilities :

Lead and coordinate GMP clean room re-qualification activities in compliance with Annex 1 standards.

Execute existing validation protocols accurately and on schedule.

Collaborate with manufacturing teams to schedule and coordinate testing with minimal disruption.

Provide leadership during dynamic room testing, ensuring proper personnel management, signage, and compliance.

Partner with QC Laboratories to facilitate climate viable and non-viable environmental monitoring.

Write or revise validation protocols using paper-based templates, ensuring regulatory and internal compliance.

Required Experience :

5 10 years of validation experience within pharmaceutical GMP clean room environments.

Strong knowledge of Annex 1 requirements and clean room re-qualification processes.

Proven ability to lead and coordinate teams during validation and testing activities.

Experience with paper-based validation documentation systems (no Kneat).

Familiarity with environmental monitoring, including Climet sampling.

Excellent organizational and communication skills.