Sterile Validation Lead — Biopharma Quality & Compliance

ADP, Inc.; Costa Mesa (CA); On-site; USD 110,000 - 125,000; Full time

Job summary

ADP, Inc. is seeking a Senior Validation Engineer in Costa Mesa, CA to lead validation for sterile injectable operations. You will drive DQ/IQ/OQ/PQ, author protocols, and deliver final reports while maintaining VMPs and ensuring regulatory compliance.

You will collaborate cross-functionally with manufacturing, quality, and validation groups to ensure facilities, utilities, and systems stay in a validated state per FDA, EU GMP, and ICH guidelines.

Qualifications

• 7+ years of hands-on validation in sterile injectable/pharmaceutical or biopharmaceutical environments.
• Experience with DQ, IQ, OQ, PQ and validation lifecycle steps.
• Knowledge of FDA cGMPs and EU GMP Annex 1 for sterile manufacturing.

Responsibilities

• Lead and execute DQ, IQ, OQ, and PQ activities for aseptic filling lines, isolators, autoclaves, SIP/CIP systems, and cleanrooms.
• Author, review, and approve validation protocols, perform executions, review data, and write final reports.
• Develop and maintain Validation Master Plans (VMPs) and contribute to continuous improvement.

Skills

Aseptic processing

Regulatory compliance

Technical leadership

Data integrity

Process validation

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MS Office Suite

Job description

ADP, Inc. is seeking a Senior Validation Engineer in Costa Mesa, CA to lead validation for sterile injectable operations. You will drive DQ/IQ/OQ/PQ, author protocols, and deliver final reports while maintaining VMPs and ensuring regulatory compliance.

You will collaborate cross-functionally with manufacturing, quality, and validation groups to ensure facilities, utilities, and systems stay in a validated state per FDA, EU GMP, and ICH guidelines.