Validation Consultant

Validation Consultant

Location: Los Angeles, California (Onsite)

No H1B

JD:

Our client, a leading pharmaceutical manufacturer, is seeking an experienced Validation Consultant to support GMP clean room re-qualification efforts in alignment with Annex 1 requirements. This contract role will primarily focus on executing existing protocols and coordinating clean room testing with manufacturing teams, along with authoring and executing new protocols. The project will be conducted within a paper-based validation system environment. The project is scheduled to be completed by the end of December 2025. This is an onsite position in Los Angeles, CA.

Key Responsibilities:

• Lead and coordinate GMP clean room re-qualification activities in compliance with Annex 1 standards.
• Execute existing validation protocols, ensuring accurate documentation and adherence to timelines.
• Collaborate closely with manufacturing teams to schedule and coordinate testing time slots with minimal disruption.
• Provide leadership during dynamic room testing, including managing personnel, ensuring appropriate room signage, and maintaining compliance.
• Partner with QC Laboratories to facilitate Climet viable and non-viable environmental monitoring during re-qualification activities.
• Write or revise protocols using client-provided paper-based templates, ensuring compliance with regulatory and internal standards.

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.