CQV Consultant - California

Join a leading biopharmaceutical manufacturer in the San Diego area as a Senior Validation Engineer supporting equipment and cleaning validation at a large-scale biologics manufacturing site. This is a hands-on contract role where you'll drive validation for upcoming tech transfers and equipment qualifications in a cGMP environment — a strong fit if you want high-impact field work at an established, stable operation without relocating out of Southern California.

Responsibilities

Author and execute validation protocols for equipment and systems, including cleaning validation; Lead troubleshooting and data analysis for validation test results; Support tech transfers, equipment modifications, and requalification activities; Maintain precise, audit-ready validation records and documentation; Ensure all deliverables align with applicable industry and regulatory standards; Partner cross-functionally with engineering, manufacturing, and quality teams to keep projects on schedule

Requirements

10+ years of validation experience in a cGMP biopharmaceutical or life sciences environment; Demonstrated depth in equipment validation and cleaning validation; Strong protocol authoring and technical writing skills; Proven technical problem-solving and data analysis capability; Must be legally eligible to work in the United States without company sponsorship

Nice to have

Experience supporting tech transfers or equipment qualification/requalification programs; Familiarity with automated process systems and control platforms (e.g., DeltaV); Track record collaborating across engineering, operations, and quality functions

Benefits

Premium medical coverage; 401(k) with company match; Tuition reimbursement; Unique performance incentives; Employee Stock Ownership Plan