CQV Engineer

Job Title: CQV Engineer Location: California Employment Type: Full-Time

Job Summary:

We are seeking an experienced CQV Engineer to support commissioning, qualification, and validation (CQV) activities for GMP-regulated facilities and equipment, particularly within the biopharma and life sciences industry. This role focuses on temperature mapping, clean room qualifications, and validation of critical systems and process equipment.

Key Responsibilities:

Perform temperature mapping for Controlled Temperature Units (CTUs), including freezers and refrigerators.

Conduct validation of Analytical Equipment and Clean Room Qualification.

Develop and execute commissioning and validation protocols (IQ, OQ, PQ) for bioprocess equipment.

Prepare and review validation plans, protocols, and reports in compliance with cGMP guidelines.

Analyze validation data, summarize results, and compile final report packages.

Participate in OOS (Out-of-Specification) investigations and determine corrective actions.

Conduct system walk-downs (P&IDs) prior to study executions.

Ensure adherence to current Good Manufacturing Practices (cGMP) and regulatory standards.

Maintain document databases and track validation report progress.

Review executed protocols for completeness and accuracy.

Collaborate with cross-functional teams and provide technical expertise.

Required Qualifications:

Bachelor's degree (or higher) in Chemical Engineering, Life Sciences, or a related technical discipline.

4–10 years of hands-on CQV experience in a GMP-regulated environment.

Proven expertise in temperature mapping and clean room qualification.

Experience with Biopharma process equipment commissioning and validation.

Strong understanding of the Validation Lifecycle (URS, FRS, FAT, SAT, IQ, OQ, PQ).

Familiarity with regulatory requirements (FDA, EMA, ICH guidelines, etc.).

Skilled in traditional, risk-based, and hybrid validation approaches.

Experience using GLIMS or thermal equipment is a plus.

Excellent analytical, organizational, and communication skills.

Proficient in Microsoft Office and related software tools.

Ability to work independently and within a team environment.